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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01301378

Enrollment

Registered

2011-02-23

Start date

2010-08-31

Completion date

2011-01-31

Last updated

2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREMolteno 3 glaucoma drainage shunt

Patients needing glaucoma drainage surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026