Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
|ClinicalTrials.gov Identifier: NCT01241279|
Recruitment Status : Terminated (Terminated due to low enrollment)
First Posted : November 16, 2010
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: Crystalens AO Device: SoftPort LI61AO||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||October 2010|
|Primary Completion Date :||November 2011|
|Study Completion Date :||December 2011|
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.
- Amplitude of Accommodation [ Time Frame: Visit 4 (postoperative day 120-180) ]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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241279
|United States, California|
|Bausch & Lomb|
|Irvine, California, United States, 92618|
|Study Director:||Johnson Varughese||Valeant Pharmaceuticals/Bausch & Lomb Incorporated|