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

Primary Purpose

Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Pseudoexfoliation Glaucoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Molteno 3 glaucoma drainage shunt

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wills Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

KeraSys Tissue Patch Graft

Tutoplast tissue patch graft

Arm Description

20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft

20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft

Outcomes

Primary Outcome Measures

Kerasys safety

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

The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos.

Full Information

NCT ID

NCT01301378

First Posted

February 22, 2011

Last Updated

November 20, 2016

Sponsor

Wills Eye

Collaborators

IOP Ophthalmics

1. Study Identification

Unique Protocol Identification Number

NCT01301378

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Terminated

Why Stopped

kerasys had more erosions than tutoplast

Study Start Date

August 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wills Eye

Collaborators

IOP Ophthalmics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KeraSys Tissue Patch Graft

Arm Type

Active Comparator

Arm Description

20 patients needing a Molteno 3 glaucoma drainage shunt implant will receive the KeraSys patch graft

Arm Title

Tutoplast tissue patch graft

Arm Type

Active Comparator

Arm Description

20 patients need Molteno 3 glaucoma drainage surgery will receive tutoplast patch graft

Intervention Type

Procedure

Intervention Name(s)

Molteno 3 glaucoma drainage shunt

Other Intervention Name(s)

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

Intervention Description

Patients needing glaucoma drainage surgery

Primary Outcome Measure Information:

Title

Kerasys safety

Description

The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction.

Time Frame

one day, week one, 1 month, 3 month, 6 month, and 1 year

Secondary Outcome Measure Information:

Title

Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery

Description

The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos.

Time Frame

1 month, 3 month, 6 month, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marlene M Moster, MD

Organizational Affiliation

Wills Eye Institute Glaucoma Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wills Eye Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18303385

Citation

Lankaranian D, Reis R, Henderer JD, Choe S, Moster MR. Comparison of single thickness and double thickness processed pericardium patch graft in glaucoma drainage device surgery: a single surgeon comparison of outcome. J Glaucoma. 2008 Jan-Feb;17(1):48-51. doi: 10.1097/IJG.0b013e318133fc49.

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

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