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

This study has been terminated.
(kerasys had more erosions than tutoplast)
IOP Ophthalmics
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye Identifier:
First received: February 22, 2011
Last updated: November 20, 2016
Last verified: November 2016
The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery

Condition Intervention
Primary Open Angle Glaucoma Primary Angle Closure Glaucoma Pseudoexfoliation Glaucoma Pigmentary Glaucoma Traumatic Glaucoma Uveitic Glaucoma Neovascular Glaucoma Procedure: Molteno 3 glaucoma drainage shunt

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Marlene Moster, MD, Wills Eye:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 40
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01301378

United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
IOP Ophthalmics
Principal Investigator: Marlene M Moster, MD Wills Eye Institute Glaucoma Department
  More Information

Responsible Party: Marlene Moster, MD, Marlene Moster, MD Principal Investigator, Wills Eye Institute Glaucoma Department, Wills Eye Identifier: NCT01301378     History of Changes
Other Study ID Numbers: 09-956 KeraSys
Study First Received: February 22, 2011
Last Updated: November 20, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Glaucoma, Angle-Closure
Glaucoma, Neovascular
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases processed this record on September 25, 2017