Clinical Trial: Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Comparison of Porcine Submucosal Tissue Patch Graft (KeraSys) Versus Processed Pericardium Patch Graft (Tutoplast) in Glaucoma Drainage Implant Surgery Using a Molteno 3 Shunt

Brief Summary: The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery

Detailed Summary: This study compares patients who will undergo Molteno 3 shunt implant surgery with 1 group receiving KeraSys patch graft and the 2nd group receiving Tutoplast patch graft. The investigators will examine the efficacy and safety of KeraSys in comparison with Tutoplast and monitor the long term effectiveness for preventing tube erosion in Molteno 3 tube shunt surgery for 1 year.
Sponsor: Wills Eye

Current Primary Outcome: Kerasys safety [ Time Frame: one day, week one, 1 month, 3 month, 6 month, and 1 year ]

The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction.


Original Primary Outcome: Same as current

Current Secondary Outcome: Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery [ Time Frame: 1 month, 3 month, 6 month, 1 year ]

The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos.


Original Secondary Outcome: Same as current

Information By: Wills Eye

Dates:
Date Received: February 22, 2011
Date Started: August 2010
Date Completion:
Last Updated: November 20, 2016
Last Verified: November 2016