NCT01248572

Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL

Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Lenstec Incorporated · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cataract

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-11-25
• Last updated: 2014-03-18

Locations

3 sites across 1 country: United States