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)
65
Enrollment
3
Locations
2
Arms
21.7
Patients Per Site

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1The Eye Center of North FloridaPanama CityFloridaUnited States32405
2Carolina Eye Care PhysiciansCharlestonSouth CarolinaUnited States29414
3Whitsett Vision GroupHoustonTexasUnited States77055

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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsBilateral diagnosis of cataracts of subjects >21 years of age
Pre-assignment DetailDuring the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Arm/Group TitleReSTOR +3Tecnis MF
Arm/Group DescriptionBilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extractionBilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
Period Title: Overall Study
STARTED3331
COMPLETED3230
NOT COMPLETED11

Baseline Characteristics

Arm/Group TitleReSTOR +3Tecnis MFTotal
Arm/Group DescriptionBilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extractionBilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extractionTotal of all reporting groups
Overall Participants333164
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
TitleDefocus Curve
DescriptionA 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 Frame3 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 TitleReSTOR +3Tecnis MF
Arm/Group DescriptionBilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extractionBilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
Measure Participants3329
-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 FrameAdverse events were collected at all study visits.
Adverse Event Reporting Description
Arm/Group TitleReSTOR +3Tecnis MF
Arm/Group DescriptionBilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extractionBilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
All Cause Mortality
ReSTOR +3Tecnis MF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
ReSTOR +3Tecnis MF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/32 (0%) 0/30 (0%)
Other (Not Including Serious) Adverse Events
ReSTOR +3Tecnis MF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/32 (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").

Results Point of Contact

Name/TitleDirector of Alcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
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