Evaluation of 3 Intraocular Lenses Following Lens Extraction

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT01122576

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Crystalens AO Device: ReSTOR Device: Tecnis Multifocal IOL	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crystalens AO Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.	Device: Crystalens AO Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
Active Comparator: ReSTOR Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.	Device: ReSTOR ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
Active Comparator: Tecnis Multifocal IOL Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.	Device: Tecnis Multifocal IOL Tecnis surgically implanted bilaterally. Study observation up to 180 days.

Arm

Intervention/Treatment

Experimental: Crystalens AO

Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.

Device: Crystalens AO

Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.

Active Comparator: ReSTOR

Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.

Device: ReSTOR

ReSTOR surgically implanted bilaterally. Study observation up to 180 days.

Active Comparator: Tecnis Multifocal IOL

Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.

Device: Tecnis Multifocal IOL

Tecnis surgically implanted bilaterally. Study observation up to 180 days.

Outcome Measures

Primary Outcome Measures

Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree [Postoperative visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree [Postoperative visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree [Postoperative visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree [Postoperative visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree [Postoperative visit 4 ( 4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree [Postoperative visit 4 ( 4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree [Postoperative visit 4 ( 4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree [Postoperative visit 4 ( 4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree [Postoperative visit 4 ( 4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Secondary Outcome Measures

Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree [Visit 3 (2-3 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree [Visit 4 (4-6 months)]
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Optical Scatter [Visit 3 (2-3 months)]
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Optical Scatter [Visit 4 (4-6 months)]
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Monocular Halo and Starburst [Visit 3 (2-3 months)]
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Monocular Halo and Starburst [Visit 4 (4-6 months)]
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Binocular Halo and Starburst [Visit 3 (2-3 months)]
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Binocular Halo and Starburst [Visit 4 (4-6 months)]
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Manifest Refraction [Visit 3 (2-3 Months)]
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Manifest Refraction [Visit 4 (4-6 Months)]
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Uncorrected Distance Visual Acuity [Visit 3 (2-3 months) Visit 4 (4-6 months)]
High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches
Best-corrected Distance Visual Acuity [Visit 3 (2-3 months) Visit 4 (4-6 months)]
High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
Subjects must require a spherical lens power from 10.00 D to 33.00 D
Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

Exclusion Criteria:

Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb, Inc	Aliso Viejo	California	United States	92656

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

Study Director: Omid Khodai, OD, RAC, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT01122576

Other Study ID Numbers:

First Posted:

May 13, 2010

Last Update Posted:

Mar 28, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Bausch & Lomb Incorporated

Intra Ocular Lens

Ocular surgery

Phacoemulsification

Additional relevant MeSH terms:

Cataract

Study Results

Participant Flow

Recruitment Details	This study took place at two investigative sites in the United States, with the first participant undergoing cataract surgery on 5/18/2010 and last participant completed the study on 6/27/2012.
Pre-assignment Detail	Seventy eight participants (156 eyes) were enrolled in the study. 148 eyes were analyzed in both the full analysis set and the per protocol set.

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days.
Period Title: Pre-Cataract Surgery
STARTED	26	26	26
COMPLETED	26	25	24
NOT COMPLETED	0	1	2
Period Title: Pre-Cataract Surgery
STARTED	26	25	24
COMPLETED	26	25	22
NOT COMPLETED	0	0	2

Baseline Characteristics

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL	Total
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.	Total of all reporting groups
Overall Participants	26	26	26	78
Age, Customized (participants) [Number]
<40 years	0 0%	0 0%	0 0%	0 0%
40 - 49 years	0 0%	1 3.8%	1 3.8%	2 2.6%
50-59 years	10 38.5%	5 19.2%	8 30.8%	23 29.5%
60-69 years	13 50%	12 46.2%	12 46.2%	37 47.4%
70-79 years	3 11.5%	8 30.8%	4 15.4%	15 19.2%
≥ 80	0 0%	0 0%	1 3.8%	1 1.3%
Sex: Female, Male (Count of Participants)
Female	17 65.4%	15 57.7%	19 73.1%	51 65.4%
Male	9 34.6%	11 42.3%	7 26.9%	27 34.6%
Region of Enrollment (participants) [Number]
United States	26 100%	26 100%	26 100%	78 100%

Outcome Measures

1. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Measure eyes	52	50	44
1.5 cycles/degree	1.494 (0.173)	1.576 (0.209)	1.410 (0.195)
3 cycles/degree	1.613 (0.171)	1.679 (0.199)	1.528 (0.175)

2. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	23	20
Measure eyes	52	45	40
Mean (Standard Deviation) [log contrast sensitivity units]	1.563 (0.228)	1.644 (0.253)	1.481 (0.212)

3. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	16	13	9
Measure eyes	32	26	17
Mean (Standard Deviation) [log contrast sensitivity units]	1.155 (0.238)	1.335 (0.309)	1.143 (0.189)

4. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	7	10	3
Measure eyes	13	19	5
Mean (Standard Deviation) [log contrast sensitivity units]	0.943 (0.266)	0.950 (0.297)	0.697 (0.138)

5. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 4 ( 4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Measure eyes	52	50	44
Mean (Standard Deviation) [log contrast sensitivity units]	1.525 (0.203)	1.588 (0.213)	1.408 (0.172)

6. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 4 ( 4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Measure eyes	52	49	44
Mean (Standard Deviation) [log contrast sensitivity units]	1.638 (0.243)	1.698 (0.221)	1.519 (0.125)

7. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 4 ( 4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	24	21
Measure eyes	49	47	41
Mean (Standard Deviation) [log contrast sensitivity units]	1.610 (0.241)	1.622 (0.228)	1.543 (0.261)

8. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 4 ( 4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	17	15	8
Measure eyes	33	30	15
Mean (Standard Deviation) [log contrast sensitivity units]	1.229 (0.262)	1.218 (0.238)	1.217 (0.275)

9. Primary Outcome

Title	Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Postoperative visit 4 ( 4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and wer implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	9	6	3
Measure eyes	17	11	6
Mean (Standard Deviation) [log contrast sensitivity units]	0.998 (0.297)	0.789 (0.219)	0.896 (0.275)

10. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full set analysis

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	25	20
1.5 cycles/degree	1.688 (0.221)	1.749 (0.201)	1.537 (0.129)
3 cycles/degree	1.775 (0.252)	1.797 (0.213)	1.667 (0.168)

11. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	24	20
Mean (Standard Deviation) [log contrast sensitivity units]	1.731 (0.213)	1.677 (0.257)	1.593 (0.225)

12. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	21	15	8
Mean (Standard Deviation) [log contrast sensitivity units]	1.189 (0.170)	1.362 (0.323)	1.153 (0.228)

13. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	7	10	3
Mean (Standard Deviation) [log contrast sensitivity units]	0.965 (0.258)	0.994 (0.359)	0.861 (0.241)

14. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
1.5 cycles/degree	1.712 (0.212)	1.743 (0.218)	1.537 (0.147)
3 cycles/degree	1.785 (0.223)	1.768 (0.243)	1.594 (0.135)
6 cycles/degree	1.710 (0.234)	1.682 (0.268)	1.595 (0.265)

15. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	18	17	9
Mean (Standard Deviation) [log contrast sensitivity units]	1.261 (0.291)	1.273 (0.269)	1.235 (0.245)

16. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	10	10	5
Mean (Standard Deviation) [log contrast sensitivity units]	1.160 (0.356)	1.008 (0.386)	0.885 (0.287)

17. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	25	21
Measure eyes	50	49	42
Mean (Standard Deviation) [log contrast sensitivity units]	1.329 (0.172)	1.389 (0.219)	1.233 (0.182)

18. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	24	20
Measure eyes	50	48	39
Mean (Standard Deviation) [log contrast sensitivity units]	1.527 (0.190)	1.518 (0.267)	1.388 (0.245)

19. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	19	13
Measure eyes	49	38	27
Mean (Standard Deviation) [log contrast sensitivity units]	1.514 (0.217)	1.504 (0.313)	1.397 (0.265)

20. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	14	10	5
Measure eyes	27	20	10
Mean (Standard Deviation) [log contrast sensitivity units]	1.118 (0.225)	1.192 (0.235)	1.059 (0.208)

21. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	6	4	1
Measure eyes	11	8	1
Mean (Standard Deviation) [log contrast sensitivity units]	0.883 (0.199)	0.989 (0.336)	0.903 (0)

22. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	25	21
Measure eyes	49	49	42
Mean (Standard Deviation) [log contrast sensitivity units]	1.343 (0.254)	1.367 (0.229)	1.199 (0.145)

23. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	25	21
Measure eyes	49	49	41
Mean (Standard Deviation) [log contrast sensitivity units]	1.536 (0.247)	1.462 (0.212)	1.367 (0.196)

24. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	23	20	14
Measure eyes	46	39	27
Mean (Standard Deviation) [log contrast sensitivity units]	1.535 (0.274)	1.475 (0.276)	1.413 (0.265)

25. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	9	7	4
Measure eyes	18	14	7
Mean (Standard Deviation) [log contrast sensitivity units]	1.341 (0.341)	1.272 (0.358)	1.190 (0.327)

26. Secondary Outcome

Title	Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	7	3	3
Measure eyes	13	5	5
Mean (Standard Deviation) [log contrast sensitivity units]	1.139 (0.315)	1.192 (0.334)	0.849 (0.353)

27. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	24	25	19
1.5 cycles/degree	1.459 (0.239)	1.439 (0.216)	1.316 (0.210)
3 cycles/degree	1.609 (0.189)	1.492 (0.264)	1.405 (0.225)

28. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	24	20	15
Mean (Standard Deviation) [log contrast sensitivity units]	1.574 (0.183)	1.496 (0.385)	1.412 (0.261)

29. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	13	8	3
Mean (Standard Deviation) [log contrast sensitivity units]	1.199 (0.243)	1.337 (0.273)	1.141 (0.222)

30. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	5	5	2
Mean (Standard Deviation) [log contrast sensitivity units]	0.980 (0.295)	1.009 (0.096)	0.690 (0.125)

31. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	25	21
1.5 cycles/degree	1.392 (0.222)	1.404 (0.238)	1.344 (0.151)
3 cycles/degree	1.573 (0.268)	1.493 (0.304)	1.410 (0.223)

32. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	20	16
Mean (Standard Deviation) [log contrast sensitivity units]	1.519 (0.296)	1.515 (0.330)	1.448 (0.271)

33. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	9	8	2
Mean (Standard Deviation) [log contrast sensitivity units]	1.321 (0.331)	1.319 (0.450)	1.337 (0.419)

34. Secondary Outcome

Title	Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Description	Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	6	5	2
Mean (Standard Deviation) [log contrast sensitivity units]	1.175 (0.258)	1.101 (0.439)	1.060 (0.648)

35. Secondary Outcome

Title	Optical Scatter
Description	Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	25	25	23
Measure eyes	50	50	45
Mean (Standard Deviation) [units on a scale]	1.1280 (0.7661)	1.8080 (0.8685)	1.9179 (0.9751)

36. Secondary Outcome

Title	Optical Scatter
Description	Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Measure eyes	52	50	44
Mean (Standard Deviation) [units on a scale]	1.1308 (0.7337)	1.9760 (1.1630)	1.8318 (0.9840)

37. Secondary Outcome

Title	Monocular Halo and Starburst
Description	Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	23
Measure eyes	52	50	45
Halo	1.2 (0.9)	1.3 (0.8)	1.8 (0.9)
Starburst	4.5 (1.1)	4.7 (1.0)	4.5 (1.2)

38. Secondary Outcome

Title	Monocular Halo and Starburst
Description	Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Measure eyes	52	50	44
Halo	1.2 (0.6)	1.5 (0.8)	1.8 (0.7)
Starburst	4.6 (1.0)	4.7 (1.0)	4.5 (1.2)

39. Secondary Outcome

Title	Binocular Halo and Starburst
Description	Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time Frame	Visit 3 (2-3 months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Halo	1.2 (1.1)	1.4 (0.8)	2.0 (1.0)
Starburst	4.6 (1.1)	4.7 (1.0)	4.6 (0.9)

40. Secondary Outcome

Title	Binocular Halo and Starburst
Description	Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Time Frame	Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Halo	1.3 (0.7)	1.8 (1.2)	2.0 (0.9)
Starburst	4.6 (1.0)	4.9 (0.4)	4.5 (0.9)

41. Secondary Outcome

Title	Manifest Refraction
Description	Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Time Frame	Visit 3 (2-3 Months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	23
Measure eyes	52	50	45
Mean (Standard Deviation) [Diopters]	-0.507 (0.433)	0.038 (0.344)	-0.114 (0.362)

42. Secondary Outcome

Title	Manifest Refraction
Description	Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Time Frame	Visit 4 (4-6 Months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	22
Measure eyes	52	50	44
Mean (Standard Deviation) [Diopters]	-0.339 (0.455)	0.145 (0.370)	-0.091 (0.339)

43. Secondary Outcome

Title	Uncorrected Distance Visual Acuity
Description	High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches
Time Frame	Visit 3 (2-3 months) Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	23
Measure eyes	52	50	46
UCDVA Monocular Visit 3	0.122 (0.171)	0.002 (0.115)	0.072 (0.150)
UCDVA Monocular Visit 4	0.113 (0.173)	0.016 (0.121)	0.060 (0.148)
UCDVA Binocular Visit 3	0.005 (0.082)	-0.054 (0.102)	-0.048 (0.087)
UCDVA Binocular Visit 4	-0.026 (0.110)	-0.061 (0.080)	-0.053 (0.104)
UCIVA Monocular Visit 3	0.055 (0.159)	0.219 (0.150)	0.237 (0.221)
UCIVA Monocular Visit 4	0.066 (0.168)	0.244 (0.158)	0.237 (0.197)
UCIVA Binocular Visit 3	-0.012 (0.130)	0.138 (0.140)	0.126 (0.169)
UCIVA Binocular Visit 4	-0.024 (0.111)	0.169 (0.144)	0.175 (0.146)
UCNVA Monocular Visit 3	0.192 (0.189)	0.005 (0.108)	0.164 (0.149)
UCNVA Monocular Visit 4	0.264 (0.195)	-0.008 (0.120)	0.188 (0.185)
UCNVA Binocular Visit 3	0.082 (0.151)	-0.057 (0.074)	0.041 (0.109)
UCNVA Binocular Visit 4	0.133 (0.148)	-0.061 (0.087)	0.043 (0.130)

44. Secondary Outcome

Title	Best-corrected Distance Visual Acuity
Description	High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)
Time Frame	Visit 3 (2-3 months) Visit 4 (4-6 months)

Outcome Measure Data

Analysis Population Description
Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR	Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.	Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Measure Participants	26	25	23
Measure eyes	52	50	46
BCDVA Monocular Visit 3	-0.100 (0.070)	-0.094 (0.080)	-0.068 (0.098)
BCDVA Monocular Visit 4	-0.100 (0.066)	-0.096 (0.106)	-0.075 (0.088)
BCDVA Binocular Visit 3	-0.144 (0.049)	-0.133 (0.073)	0.115 (0.057)
BCDVA Binocular Visit 4	-0.136 (0.049)	-0.137 (0.058)	-0.117 (0.098)
DCIVA Monocular Visit 3	0.169 (0.144)	0.292 (0.132)	0.292 (0.162)
DCIVA Monocular Visit 4	0.186 (0.129)	0.297 (0.119)	0.328 (0.159)
DCIVA Binocular Visit 3	0.095 (0.146)	0.222 (0.112)	0.196 (0.112)
DCIVA Binocular Visit 4	0.084 (0.109)	0.229 (0.108)	0.229 (0.127)
DCNVA Monocular Visit 3	0.346 (0.130)	-0.004 (0.087)	0.132 (0.143)
DCNVA Monocular Visit 4	0.360 (0.144)	-0.042 (0.132)	0.136 (0.144)
DCNVA Binocular Visit 3	0.261 (0.109)	-0.079 (0.065)	-0.004 (0.100)
DCNVA Binocular Visit 4	0.247 (0.126)	-0.075 (0.096)	0.025 (0.127)

Adverse Events

	Crystalens AO		ReSTOR		Tecnis Multifocal IOL
Time Frame	6 months
Adverse Event Reporting Description	Serious adverse events were measured by participant where as Other adverse events were measured by eye.

Arm/Group Title	Crystalens AO		ReSTOR		Tecnis Multifocal IOL
Arm/Group Description	Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.		Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days.		Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Crystalens AO		ReSTOR		Tecnis Multifocal IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		1/25 (4%)		3/23 (13%)
Eye disorders
Vitreous hemorrhage	0/26 (0%)	0	0/25 (0%)	0	1/23 (4.3%)	1
Retinal vein occlusion	0/26 (0%)	0	1/25 (4%)	1	0/23 (0%)	0
Renal and urinary disorders
Pyelonephritis	0/26 (0%)	0	0/25 (0%)	0	1/23 (4.3%)	1
Vascular disorders
Pulmonary embolism	0/26 (0%)	0	0/25 (0%)	0	1/23 (4.3%)	1
Other (Not Including Serious) Adverse Events
	Crystalens AO		ReSTOR		Tecnis Multifocal IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/52 (19.2%)		13/50 (26%)		4/46 (8.7%)
Eye disorders
Corneal Edema	2/52 (3.8%)	2	5/50 (10%)	5	2/46 (4.3%)	2
Punctate Keratitis	8/52 (15.4%)	8	1/50 (2%)	1	2/46 (4.3%)	2
Increased Intraocular Pressure (IOP)	0/52 (0%)	0	7/50 (14%)	7	0/46 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/Title	Quintus Ngumah, OD, PhD
Organization	Bausch & Lomb Incorporated
Phone	(973) 360-6450
Email	Quintus.Ngumah@bausch.com

Responsible Party:

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT01122576

Other Study ID Numbers:

First Posted:

May 13, 2010

Last Update Posted:

Mar 28, 2014

Last Verified:

Feb 1, 2014

Evaluation of 3 Intraocular Lenses Following Lens Extraction

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

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Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact