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