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

This study has been terminated.
(kerasys had more erosions than tutoplast)
Sponsor:
Collaborator:
IOP Ophthalmics
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT01301378
First received: February 22, 2011
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Wills Eye:

Primary Outcome Measures:
  • Kerasys safety [ Time Frame: one day, week one, 1 month, 3 month, 6 month, and 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos.


Estimated 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301378

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

No publications provided

Responsible Party: Marlene Moster, MD, Marlene Moster, MD Principal Investigator, Wills Eye Institute Glaucoma Department, Wills Eye
ClinicalTrials.gov Identifier: NCT01301378     History of Changes
Other Study ID Numbers: 09-956 KeraSys
Study First Received: February 22, 2011
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Glaucoma, Neovascular
Glaucoma, Open-Angle
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 20, 2014