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NCT01301378 Clinical Trial

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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01301378
Other study ID # 09-956 KeraSys
Secondary ID
Status Terminated
Phase N/A
First received February 22, 2011
Last updated November 20, 2016
Start date August 2010
Est. completion date January 2011

Study information
Verified date November 2016
Source Wills Eye
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Molteno 3 glaucoma drainage shunt
Patients needing glaucoma drainage surgery

Locations
Country Name City State
United States Wills Eye Institute Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Wills Eye IOP Ophthalmics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
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