Presbyopia-Correcting Intraocular Lenses (IOLs)
|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.
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|