Clinical Trial: Artisan Aphakia Lens for the Correction of Aphakia in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Artisan Aphakia Lens for the Correction of Aphakia in Children

Brief Summary: The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.

Detailed Summary:
Sponsor: Ophtec USA

Current Primary Outcome: Best corrected distance visual acuity at 12 months postoperative [ Time Frame: 5 years follow up ]

Determination of the ability of the lens to correct refractive error caused by aphakia


Original Primary Outcome: Uncorrected visual acuity at 1 year postoperative [ Time Frame: 5 years follow up ]

Determination of the ability of the lens to correct refractive error caused by aphakia


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ophtec USA

Dates:
Date Received: February 27, 2012
Date Started: January 2012
Date Completion: December 2021
Last Updated: January 31, 2016
Last Verified: January 2016