Clinical Trial: Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.
Detailed Summary:
Sponsor: Clinical Research Consultants, Inc.
Current Primary Outcome:
- Changes in Symptoms [ Time Frame: SCR & 6 Month ]Quality of vision will be assessed using the National Eye Institute Visual Functioning Questionnaire - 25.
- Participant Satisfaction [ Time Frame: SCR & 6 Month ]Participant satisfaction will be assessed using the Global Aesthetic Improvement Scale.
- Complications and Adverse Events [ Time Frame: SCR & 6 Month ]Complications and adverse events will be assessed through tabulation of adverse events, changes in vision, cell density, intraocular pressure, and slit lamp exam.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Clinical Research Consultants, Inc.
Dates:
Date Received: May 20, 2013
Date Started: October 2013
Date Completion: December 2017
Last Updated: April 7, 2017
Last Verified: April 2017