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

Study Overview
=================
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 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.

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

Conditions
-----------------
Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma, Traumatic Glaucoma, Uveitic Glaucoma, Neovascular Glaucoma

Intervention / Treatment
-----------------
* Procedure: Molteno 3 glaucoma drainage shunt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma Exclusion Criteria: Age ≤ 18 years old. Any type of glaucoma other than those listed in the inclusion criteria. Less than 3 months of other ocular surgery. Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease. Patients with connective tissue disorder. Patients with congenital or developmental glaucoma. Patients with severe dry eye syndrome. Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt. Patients undergoing any surgical concomitant surgical procedure involving the posterior segment. Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease. Patients with any prior history of allergy to the active compound. Pregnancy or breast-feeding. Patients enrolled in other prospective clinical trials. Patients that plan to use contact lens after surgery.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KeraSys Tissue Patch Graft<br>20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft | Procedure: Molteno 3 glaucoma drainage shunt<br>* Patients needing glaucoma drainage surgery<br>* Other names: Processed Pericardium Patch Graft (Tutoplast);|
| Active Comparator: Tutoplast tissue patch graft<br>20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft | Procedure: Molteno 3 glaucoma drainage shunt<br>* Patients needing glaucoma drainage surgery<br>* Other names: Processed Pericardium Patch Graft (Tutoplast);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kerasys safety | The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction. | one day, week one, 1 month, 3 month, 6 month, and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery | The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos. | 1 month, 3 month, 6 month, 1 year |