A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01166971
• Collaborator: (none)
• Enrollment: 65
• Locations: 3
• Arms: 2
• Patients Per Site: 21.7

Study Details

Study Description

Brief Summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: ReSTOR +3; Device: Tecnis MF	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR +3 Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction	Device: ReSTOR +3; Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction
Active Comparator: Tecnis MF Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction	Device: Tecnis MF; Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Outcome Measures

Primary Outcome Measures

1. Defocus Curve [3 months after surgery]

   A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosed with bilateral cataracts

• candidate for presbyopic lens

Exclusion Criteria:

• 1 Diopter (D) preoperative astigmatism by Keratometry (K)readings

• pre-existing conditions that could skew the results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Eye Center of North Florida	Panama City	Florida	United States	32405
2	Carolina Eye Care Physicians	Charleston	South Carolina	United States	29414
3	Whitsett Vision Group	Houston	Texas	United States	77055

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01166971
• Other Study ID Numbers: M09-050
• First Posted: Jul 21, 2010
• Last Update Posted: Nov 24, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Alcon Research: presbyopia; intraocular lens
• Additional relevant MeSH terms: Cataract; Presbyopia

Study Results

Participant Flow

Recruitment Details	Bilateral diagnosis of cataracts of subjects >21 years of age
Pre-assignment Detail	During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.

Arm/Group Title	ReSTOR +3	Tecnis MF
Arm/Group Description	Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction	Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
Period Title: Overall Study
STARTED	33	31
COMPLETED	32	30
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	ReSTOR +3	Tecnis MF	Total
Arm/Group Description	Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction	Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction	Total of all reporting groups
Overall Participants	33	31	64
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 57.6%	10 32.3%	29 45.3%
>=65 years	14 42.4%	21 67.7%	35 54.7%
Sex: Female, Male (Count of Participants)
Female	18 54.5%	20 64.5%	38 59.4%
Male	15 45.5%	11 35.5%	26 40.6%

Outcome Measures

1. Primary Outcome

Title	Defocus Curve
Description	A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".
Time Frame	3 months after surgery

Outcome Measure Data

Analysis Population Description

In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.

Arm/Group Title	ReSTOR +3	Tecnis MF
Arm/Group Description	Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction	Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
Measure Participants	33	29
-5.00 Diopter (D)	0.585 (0.204)	0.653 (0.116)
-4.50 D	0.490 (0.204)	0.475 (0.115)
-4.00 D	0.388 (0.189)	0.337 (0.107)
-3.50 D	0.261 (0.183)	0.168 (0.114)
-3.00 D	0.126 (0.185)	0.046 (0.104)
-2.50 D	0.017 (0.144)	0.073 (0.113)
-2.00 D	0.055 (0.147)	0.222 (0.178)
-1.50 D	0.245 (0.175)	0.326 (0.120)
-1.00 D	0.212 (0.144)	0.225 (0.128)
-0.50 D	0.052 (0.132)	0.072 (0.120)
0.00 D	-0.048 (0.097)	-0.044 (0.085)
0.50 D	0.035 (0.112)	0.032 (0.111)
1.00 D	0.258 (0.140)	0.237 (0.200)
1.50 D	0.434 (0.153)	0.364 (0.176)
2.00 D	0.539 (0.168)	0.446 (0.136)

Adverse Events

Time Frame	Adverse events were collected at all study visits.
Arm/Group Title	ReSTOR +3		Tecnis MF
Arm/Group Description	Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction		Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
All Cause Mortality
	ReSTOR +3		Tecnis MF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ReSTOR +3		Tecnis MF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	ReSTOR +3		Tecnis MF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The existence of this clinical study is confidential and should not be discussed with persons outside of the study. You shall hold confidential, and not disclose directly or indirectly to any third party other than those persons involved in the study who have a need to know, the protocol, the data arising out of the study, and any other information related to the study or to Alcon's products or research programs that is provided by Alcon to you (the "Confidential Information").