Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL
The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens|
- Effective Lens Position [ Time Frame: 6 Months Postoperative ] [ Designated as safety issue: No ]The position of the intraocular lens - defined by measurement of the aqueous-containing space between the corneal endothelium and the anterior surface of the intraocular lens - once implanted in the capsular bag.
|Study Start Date:||October 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Softec HD IOL||
Device: Softec HD IOL
Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.
The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248572
|United States, Arizona|
|Barnet-Dulaney-Perkins Eye Center|
|Phoenix, Arizona, United States, 85016|
|United States, Florida|
|Eye Centers of Florida|
|Ft. Myers, Florida, United States, 33901|
|United States, Georgia|
|Rome, Georgia, United States, 30165|