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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2011

Last Updated Date

December 20, 2012

Start Date ^ICMJE

August 2010

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01301378 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Open Angle Glaucoma
Primary Angle Closure Glaucoma
Pseudoexfoliation Glaucoma
Pigmentary Glaucoma
Traumatic Glaucoma
Uveitic Glaucoma
Neovascular Glaucoma

Intervention ^ICMJE

Procedure: Molteno 3 glaucoma drainage shunt

Patients needing glaucoma drainage surgery

Other Names:

Porcine Submucosal Tissue Patch Graft (Kerasys)
Processed Pericardium Patch Graft (Tutoplast)

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma

Exclusion Criteria:

Age ≤ 18 years old.
Any type of glaucoma other than those listed in the inclusion criteria.
Less than 3 months of other ocular surgery.
Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
Patients with connective tissue disorder.
Patients with congenital or developmental glaucoma.
Patients with severe dry eye syndrome.
Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt.
Patients undergoing any surgical concomitant surgical procedure involving the posterior segment.
Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease.
Patients with any prior history of allergy to the active compound.
Pregnancy or breast-feeding.
Patients enrolled in other prospective clinical trials.
Patients that plan to use contact lens after surgery.

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01301378

Other Study ID Numbers ^ICMJE

09-956 KeraSys

Has Data Monitoring Committee

Yes

Responsible Party

Marlene Moster, MD, Wills Eye

Study Sponsor ^ICMJE

Wills Eye

Collaborators ^ICMJE

IOP Ophthalmics

Investigators ^ICMJE

Principal Investigator:

Marlene M Moster, MD

Wills Eye Institute Glaucoma Department

Information Provided By

Wills Eye

Verification Date

December 2012

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

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