Trials / Terminated
TerminatedNCT01301378
Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube
Comparison of Porcine Submucosal Tissue Patch Graft (KeraSys) Versus Processed Pericardium Patch Graft (Tutoplast) in Glaucoma Drainage Implant Surgery Using a Molteno 3 Shunt
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Wills Eye · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
- Primary Open Angle Glaucoma
- Primary Angle Closure Glaucoma
- Pseudoexfoliation Glaucoma
- Pigmentary Glaucoma
- Traumatic Glaucoma
- Uveitic Glaucoma
- Neovascular Glaucoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Molteno 3 glaucoma drainage shunt | Patients needing glaucoma drainage surgery |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2011-02-23
- Last updated
- 2016-11-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01301378. Inclusion in this directory is not an endorsement.