Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses|
- Amplitude of Accommodation [ Time Frame: Visit 4 (postoperative day 120-180) ] [ Designated as safety issue: No ]The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.
- Visual Acuity [ Time Frame: All visits through visit 4 (day 160-180) ] [ Designated as safety issue: No ]Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.
|Study Start Date:||October 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Crystalens AO
A silicone multi-piece accommodating intraocular lens
Device: Crystalens AO
Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.
Active Comparator: SoftPort LI61AO
A silicone multi-piece foldable aspheric intraocular lens
Device: SoftPort LI61AO
Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241279
|United States, California|
|Bausch & Lomb|
|Irvine, California, United States, 92618|
|Study Director:||Johnson Varughese||Valeant Pharmaceuticals/Bausch & Lomb Incorporated|