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

November 20, 2016 updated by: Marlene Moster, MD, Wills Eye

Comparison of Porcine Submucosal Tissue Patch Graft (KeraSys) Versus Processed Pericardium Patch Graft (Tutoplast) in Glaucoma Drainage Implant Surgery Using a Molteno 3 Shunt

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: KeraSys Tissue Patch Graft
20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft
Procedure: Molteno 3 glaucoma drainage shunt
Patients needing glaucoma drainage surgery
Other Names:
  • Porcine Submucosal Tissue Patch Graft (Kerasys)
  • Processed Pericardium Patch Graft (Tutoplast)
ACTIVE_COMPARATOR: Tutoplast tissue patch graft
20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft
Procedure: Molteno 3 glaucoma drainage shunt
Patients needing glaucoma drainage surgery
Other Names:
  • Porcine Submucosal Tissue Patch Graft (Kerasys)
  • Processed Pericardium Patch Graft (Tutoplast)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kerasys safety
Time Frame: 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.
one day, week one, 1 month, 3 month, 6 month, and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery
Time Frame: 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.
1 month, 3 month, 6 month, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Collaborators

IOP Ophthalmics

Investigators

  • Principal Investigator: Marlene M Moster, MD, Wills Eye Institute Glaucoma Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (ESTIMATE)

February 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 20, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-956 KeraSys

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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