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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01301378
Recruitment Status : Terminated (kerasys had more erosions than tutoplast)
First Posted : February 23, 2011
Last Update Posted : November 22, 2016
IOP Ophthalmics
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye

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

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Primary Angle Closure Glaucoma Pseudoexfoliation Glaucoma Pigmentary Glaucoma Traumatic Glaucoma Uveitic Glaucoma Neovascular Glaucoma Procedure: Molteno 3 glaucoma drainage shunt Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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)

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01301378

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

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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
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Glaucoma, Angle-Closure
Glaucoma, Neovascular
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases