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

Wills Eye

Status: Terminated

Conditions: Uveitic Glaucoma; Primary Angle Closure Glaucoma; Primary Open Angle Glaucoma; Traumatic Glaucoma; Neovascular Glaucoma; Pigmentary Glaucoma; Pseudoexfoliation Glaucoma

Treatments: Procedure: Molteno 3 glaucoma drainage shunt

Study type: Interventional

Funder types: Other

Identifiers

NCT01301378

09-956 KeraSys

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

KeraSys Tissue Patch Graft

Active Comparator group

Description:

20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft

Treatment:

Procedure: Molteno 3 glaucoma drainage shunt

Tutoplast tissue patch graft

Active Comparator group

Description:

20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft

Treatment:

Procedure: Molteno 3 glaucoma drainage shunt