Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL
Recruitment status was Recruiting
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|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||July 2011 (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 analysed for determination of ELP prediction via one, or a combination of preoperative variables.
|Contact: Erin Hayes, MSfirstname.lastname@example.org|
|United States, Arizona|
|Barnet-Dulaney-Perkins Eye Center||Recruiting|
|Phoenix, Arizona, United States, 85016|
|Contact: Patti Crincoli 602-508-4871|
|United States, Florida|
|Eye Centers of Florida||Recruiting|
|Ft. Myers, Florida, United States, 33901|
|Contact: Leigh Wilson, COS 239-939-3456|
|United States, Georgia|
|Rome, Georgia, United States, 30165|
|Contact: Cherilyn Donovan, RN 706-236-6321|