Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01225952
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

The objective of this study is to compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Crystalens AO; Device: ReSTOR 3.0; Device: AMO Tecnis Multifocal	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 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: Jul 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crystalens AO Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	Device: Crystalens AO; Bausch & Lomb model silicone multi-piece accommodating IOL.
Active Comparator: ReSTOR 3.0 An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	Device: ReSTOR 3.0; An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
Active Comparator: AMO Tecnis Multifocal A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL	Device: AMO Tecnis Multifocal; The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.

Outcome Measures

Primary Outcome Measures

1. Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

2. Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

3. Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

4. Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

5. Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

6. Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

7. Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

8. Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

Secondary Outcome Measures

1. Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

2. Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

3. Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

4. Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

5. Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

6. Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

7. Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

8. Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

   In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

9. Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

   In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

10. Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

11. Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

12. Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

13. Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) [Postoperative visit 3 (day 30-60)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

14. Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

15. Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

16. Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

17. Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

18. Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) [Postoperative visit 4 (day 120-180)]

    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must be undergoing primary IOL implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

• Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D.

• Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes.

• Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery.

• At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture.

• Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes.

Exclusion Criteria:

• Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse.

• Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.

• 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 uncontrolled glaucoma.

• Subjects with previous retinal detachment.

• Subjects with visually significant diabetic retinopathy (proliferative or nonproliferative) which reduces potential acuity to 20/32 or worse.

• Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.

• Subjects with marked microphthalmos or aniridia.

• Subjects who have had previous corneal surgery.

• Subjects with irregular corneal astigmatism.

• Subjects with amblyopia which reduces potential acuity to 20/32 or worse.

• Subjects with optic atrophy.

• Subjects with iris neovascularization.

• Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse.

• Subjects with chronic use of systemic steroids or immunosuppressive medications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asian Eye Institute	Makati City		Philippines	1200

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Tes Ignacio, MD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01225952
• Other Study ID Numbers: 656
• First Posted: Oct 21, 2010
• Last Update Posted: Jan 18, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by Bausch & Lomb Incorporated: phacoemulsification; intraocular lens
• Additional relevant MeSH terms: Cataract; Myopia

Study Results

Participant Flow

Recruitment Details	This study was an evaluation of three United States Food and Drug Administration (FDA) approved IOLs. A total of 93 participants(186 eyes) were enrolled at one investigative site in the Philippines. First participant was enrolled 7/15/2010 and last participant exited the study 4/28/2011.
Pre-assignment Detail	186 participant eyes were enrolled in this study 154 participant eyes completed the study. Participants underwent bilateral phacoemulsification and IOL implantation. Participants were randomized to treatment groups prior to surgery.

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Period Title: Overall Study
STARTED	31	31	31
COMPLETED	25	27	25
NOT COMPLETED	6	4	6

Baseline Characteristics

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal	Total
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL	Total of all reporting groups
Overall Participants	31	31	31	93
Age, Customized (participants) [Number]
< 40 years	0 0%	0 0%	0 0%	0 0%
40 - 49 years	2 6.5%	1 3.2%	0 0%	3 3.2%
50 - 59 years	6 19.4%	8 25.8%	7 22.6%	21 22.6%
60 - 69 years	13 41.9%	14 45.2%	16 51.6%	43 46.2%
70 - 79 years	10 32.3%	8 25.8%	7 22.6%	25 26.9%
>/= 80 years	0 0%	0 0%	1 3.2%	1 1.1%
Sex: Female, Male (Count of Participants)
Female	23 74.2%	25 80.6%	22 71%	70 75.3%
Male	8 25.8%	6 19.4%	9 29%	23 24.7%
Region of Enrollment (participants) [Number]
Philippines	31 100%	31 100%	31 100%	93 100%

Outcome Measures

1. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	26	27	25
Measure eyes	52	54	50
1.5 cycles/degree	1.612 (0.229)	1.582 (0.231)	1.527 (0.248)
3 cycles/degree	1.658 (0.195)	1.627 (0.224)	1.629 (0.240)

2. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set, non-missing

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	26	25	24
Measure eyes	51	50	48
Mean (Standard Deviation) [log contrast sensitivity units]	1.641 (0.210)	1.611 (0.237)	1.641 (0.286)

3. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Description	In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	26	27	25
1.5 cycles/degree	1.770 (0.187)	1.656 (0.238)	1.605 (0.203)
3 cycles/degree	1.807 (0.199)	1.679 (0.275)	1.689 (0.189)

4. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	25	26	25
Mean (Standard Deviation) [log contrast sensitivity units]	1.825 (0.216)	1.591 (0.274)	1.700 (0.284)

5. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set, non-missing

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	24	22	21
Measure eyes	48	43	42
Mean (Standard Deviation) [log contrast sensitivity units]	1.325 (0.226)	1.227 (0.198)	1.324 (0.281)

6. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set, non-missing

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	17	13	15
Measure eyes	34	26	30
Mean (Standard Deviation) [log contrast sensitivity units]	0.977 (0.266)	0.985 (0.185)	0.973 (0.342)

7. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	25	27	25
Measure eyes	50	54	50
1.5 cycles/degree	1.696 (0.213)	1.621 (0.222)	1.527 (0.190)
3 cycles/degree	1.678 (0.159)	1.670 (0.236)	1.630 (0.203)

8. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	24	26	24
Measure eyes	48	51	48
Mean (Standard Deviation) [log contrast sensitivity units]	1.579 (0.239)	1.499 (0.230)	1.610 (0.228)

9. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	20	18	20
Measure eyes	39	35	40
Mean (Standard Deviation) [log contrast sensitivity units]	1.280 (0.245)	1.225 (0.253)	1.230 (0.248)

10. Primary Outcome

Title	Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description	A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	13	10	9
Measure eyes	25	20	18
Mean (Standard Deviation) [log contrast sensitivity units]	0.974 (0.303)	0.980 (0.246)	0.976 (0.207)

11. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	25	21	22
Mean (Standard Deviation) [log contrast sensitivity units]	1.425 (0.221)	1.335 (0.218)	1.361 (0.278)

12. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	19	15	16
Mean (Standard Deviation) [log contrast sensitivity units]	1.029 (0.250)	1.001 (0.213)	0.981 (0.362)

13. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Description	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	25	27	25
1.5 cycles/degree	1.797 (0.183)	1.751 (0.238)	1.577 (0.206)
3 cycles/degree	1.851 (0.178)	1.723 (0.239)	1.702 (0.219)

14. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	24	25	24
Mean (Standard Deviation) [log contrast sensitivity units]	1.758 (0.280)	1.640 (0.236)	1.690 (0.263)

15. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	21	18	22
Mean (Standard Deviation) [log contrast sensitivity units]	1.371 (0.247)	1.269 (0.257)	1.310 (0.286)

16. Secondary Outcome

Title	Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description	In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	16	12	12
Mean (Standard Deviation) [log contrast sensitivity units]	1.115 (0.299)	0.995 (0.384)	1.041 (0.330)

17. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	26	25	25
Measure eyes	52	50	49
Mean (Standard Deviation) [log contrast sensitivity units]	1.591 (0.215)	1.519 (0.218)	1.482 (0.268)

18. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	26	25	24
Measure eyes	52	50	47
Mean (Standard Deviation) [log contrast sensitivity units]	1.687 (0.229)	1.581 (0.204)	1.588 (0.264)

19. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	25	25	23
Measure eyes	50	49	45
Mean (Standard Deviation) [log contrast sensitivity units]	1.674 (0.237)	1.531 (0.238)	1.626 (0.293)

20. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	23	18	17
Measure eyes	45	35	34
Mean (Standard Deviation) [log contrast sensitivity units]	1.328 (0.224)	1.230 (0.223)	1.340 (0.268)

21. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 3 (day 30-60)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	14	12	13
Measure eyes	27	24	25
Mean (Standard Deviation) [log contrast sensitivity units]	1.024 (0.196)	0.945 (0.158)	0.834 (0.283)

22. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	25	25	24
Measure eyes	50	50	48
Mean (Standard Deviation) [log contrast sensitivity units]	1.550 (0.263)	1.488 (0.226)	1.449 (0.206)

23. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	25	25	25
Measure eyes	50	50	49
Mean (Standard Deviation) [log contrast sensitivity units]	1.664 (0.258)	1.572 (0.225)	1.535 (0.220)

24. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	24	23	23
Measure eyes	48	46	45
Mean (Standard Deviation) [log contrast sensitivity units]	1.578 (0.252)	1.493 (0.267)	1.519 (0.260)

25. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	20	15	16
Measure eyes	39	30	31
Mean (Standard Deviation) [log contrast sensitivity units]	1.335 (0.298)	1.246 (0.278)	1.194 (0.237)

26. Secondary Outcome

Title	Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Description	In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
Time Frame	Postoperative visit 4 (day 120-180)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Crystalens AO	ReSTOR 3.0	AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens	An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.	A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Measure Participants	13	8	8
Measure eyes	25	16	16
Mean (Standard Deviation) [log contrast sensitivity units]	0.919 (0.283)	1.019 (0.367)	0.935 (0.207)

Adverse Events

Time Frame	120-180 days
Adverse Event Reporting Description	Adverse events measured by eye
Arm/Group Title	Crystalens AO		ReSTOR 3.0		AMO Tecnis Multifocal
Arm/Group Description	Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens		An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.		A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
All Cause Mortality
	Crystalens AO		ReSTOR 3.0		AMO Tecnis Multifocal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Crystalens AO		ReSTOR 3.0		AMO Tecnis Multifocal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/54 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Crystalens AO		ReSTOR 3.0		AMO Tecnis Multifocal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/53 (22.6%)		5/54 (9.3%)		6/51 (11.8%)
Eye disorders
Increased Intraocular Pressure	11/53 (20.8%)	11	5/54 (9.3%)	5	3/51 (5.9%)	3
Cystoid Macular Edema	1/53 (1.9%)	1	0/54 (0%)	0	3/51 (5.9%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor.