Clinical trial NCT01301378: Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Primary Angle Closure Glaucoma
Pseudoexfoliation Glaucoma
Pigmentary Glaucoma
Traumatic Glaucoma
Uveitic Glaucoma
Neovascular Glaucoma
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: IOP Ophthalmics
First posted: 2011-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Kerasys safety
timeFrame: one day, week one, 1 month, 3 month, 6 month, and 1 year
Secondary outcomes:
measure: Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery
timeFrame: 1 month, 3 month, 6 month, 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute Glaucoma Department
name: Marlene M Moster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lankaranian D, Reis R, Henderer JD, Choe S, Moster MR. Comparison of single thickness and double thickness processed pericardium patch graft in glaucoma drainage device surgery: a single surgeon comparison of outcome. J Glaucoma. 2008 Jan-Feb;17(1):48-51. doi: 10.1097/IJG.0b013e318133fc49.