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

Not Applicable

Terminated

• Conditions: Primary Angle Closure Glaucoma; Pseudoexfoliation Glaucoma; Neovascular Glaucoma; Primary Open Angle Glaucoma; Pigmentary Glaucoma; Traumatic Glaucoma; Uveitic Glaucoma
• Interventions: Procedure: Molteno 3 glaucoma drainage shunt

• Registration Number: NCT01301378
• Lead Sponsor: Wills Eye

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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma

Exclusion Criteria

1. Age ≤ 18 years old.
2. Any type of glaucoma other than those listed in the inclusion criteria.
3. Less than 3 months of other ocular surgery.
4. Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
5. Patients with connective tissue disorder.
6. Patients with congenital or developmental glaucoma.
7. Patients with severe dry eye syndrome.
8. Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt.
9. Patients undergoing any surgical concomitant surgical procedure involving the posterior segment.
10. Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease.
11. Patients with any prior history of allergy to the active compound.
12. Pregnancy or breast-feeding.
13. Patients enrolled in other prospective clinical trials.
14. Patients that plan to use contact lens after surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KeraSys Tissue Patch Graft	Molteno 3 glaucoma drainage shunt	20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft
Tutoplast tissue patch graft	Molteno 3 glaucoma drainage shunt	20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft

Primary Outcome Measures

Name	Time	Method
Kerasys safety	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.

Secondary Outcome Measures

Name	Time	Method
Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery	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.

Trial Locations

Locations (1)

Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States