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

NCT ID: NCT01301378

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KeraSys Tissue Patch Graft

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

Group Type ACTIVE_COMPARATOR

Molteno 3 glaucoma drainage shunt

Intervention Type PROCEDURE

Patients needing glaucoma drainage surgery

Tutoplast tissue patch graft

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

Group Type ACTIVE_COMPARATOR

Molteno 3 glaucoma drainage shunt

Intervention Type PROCEDURE

Patients needing glaucoma drainage surgery

Interventions

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Molteno 3 glaucoma drainage shunt

Patients needing glaucoma drainage surgery

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

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

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.

Exclusion Criteria

1. Age ≤ 18 years old.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

IOP Ophthalmics

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Marlene Moster, MD

Marlene Moster, MD Principal Investigator, Wills Eye Institute Glaucoma Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marlene M Moster, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Institute Glaucoma Department

Locations

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Wills Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18303385 (View on PubMed)

Other Identifiers

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09-956 KeraSys

Identifier Type: -

Identifier Source: org_study_id