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

February 22, 2011
December 20, 2012
August 2010
January 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01301378 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Open Angle Glaucoma
  • Primary Angle Closure Glaucoma
  • Pseudoexfoliation Glaucoma
  • Pigmentary Glaucoma
  • Traumatic Glaucoma
  • Uveitic Glaucoma
  • Neovascular Glaucoma
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: KeraSys Tissue Patch Graft
    20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft
    Intervention: Procedure: Molteno 3 glaucoma drainage shunt
  • Active Comparator: Tutoplast tissue patch graft
    20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft
    Intervention: Procedure: Molteno 3 glaucoma drainage shunt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301378
09-956 KeraSys
Yes
Marlene Moster, MD, Wills Eye
Wills Eye
IOP Ophthalmics
Principal Investigator: Marlene M Moster, MD Wills Eye Institute Glaucoma Department
Wills Eye
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP