Presbyopia-Correcting Intraocular Lenses (IOLs)
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|ClinicalTrials.gov Identifier: NCT00963560|
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : August 9, 2011
Last Update Posted : August 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: ReSTOR +3 Device: Crystalens HD Device: Crystalens AO||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 2011|
Experimental: ReSTOR +3
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Device: ReSTOR +3
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
Active Comparator: Crystalens HD
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Device: Crystalens HD
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
Active Comparator: Crystalens AO
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Device: Crystalens AO
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
- Best Corrected Visual Acuity [ Time Frame: 6 Months after surgery ]Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963560
|United States, Texas|
|Contact Alcon Call Center For Trial Locations|
|Fort Worth, Texas, United States, 76134|