Shunt Tube Exposure Prevention Study

NCT ID: NCT01551550

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2019-08-03

Brief Summary

This is a multi-site randomized clinical trial to evaluate the long-term efficacy of the thicker amniotic membrane graft (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) in reducing shunt tube exposure in patients undergoing glaucoma drainage device implantation.

Detailed Description

Glaucoma drainage devices (GDDs) have been used in the treatment of high-risk refractory glaucoma. To avoid tube exposure, which may lead to serious eye infection, the implanted GDD tube must be covered by a patch graft, traditionally made of either donor sclera or pericardium. However, these patch grafts still carry a high rate of progressive thinning and erosion, a complication that the investigators speculate results from the lack of cellular infiltration from the surrounding host conjunctival stroma and poor integration of these patch grafts to the host tissue. The investigators further speculate that a thicker version of cryo-preserved amniotic membrane (AM), manufactured by Bio-Tissue, Inc.,could offer better tensile strength, be suitable for tectonic support, and have biological activities to promote cellular infiltration by the surrounding host conjunctival stroma, thus reducing progressive allogeneic patch graft thinning/erosion.

Through SBIR Phase I grant support (R43 EY19785), the investigators have evaluated the thicker AM as an alternative patch graft for covering the GDD tube during the primary implantation. The investigators further monitored the host cell interaction using anterior segment optical coherence tomography (OCT). The investigators have successfully accomplished the proposed aims of the above studies, which demonstrated the short-term stability/efficacy of AM in covering the tube in primary GDD surgery (Phase I-Aim 1) and confirmed the feasibility of using OCT to distinguish host cell infiltration into the AM after transplantation over the GDD tube (Phase I-Aim 2).

In this SBIR Phase II, the investigators propose to conduct a prospective, controlled study to compare the long-term safety and efficacy of the thicker AM (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) to the pericardium (Tutoplast®, IOP Inc, Costa Mesa, CA) in securing the GDD tube and reducing tube exposure and graft thinning in patients with high risk glaucoma. The investigators will also study the risk factors that may contribute to GDD tube exposure.

Accomplishment of this Phase II study will position AM as an effective alternative to the existing patch grafts to reduce tube exposure and enhance the success of GDD implantation, while providing a better aesthetic appearance and allowing visualization of the tube in patients with high risk glaucoma. The investigators speculate that such a graft might also have other clinical applications outside of covering GDD tubes.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GDD & Amniotic Membrane Graft

After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.

Group Type: EXPERIMENTAL

GDD

Intervention Type: PROCEDURE

The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.

Amniotic Membrane Graft

Intervention Type: PROCEDURE

For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.

GDD & Pericardial Graft

After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.

Group Type: ACTIVE_COMPARATOR

GDD

Intervention Type: PROCEDURE

The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.

Pericardial Graft

Intervention Type: PROCEDURE

For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.

Interventions

GDD

The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.

Intervention Type: PROCEDURE

Amniotic Membrane Graft

For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.

Intervention Type: PROCEDURE

Pericardial Graft

For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.

Intervention Type: PROCEDURE

Other Intervention Names

Glaucoma drainage device; Tube shunt; Shunt tube; Ahmed Valve; Baerveldt valve; Amnioguard; Tutoplast

Eligibility Criteria

Inclusion Criteria

• Patients with uncontrolled glaucoma undergoing GDD implantation and carry one of the following two strata of high risk factors:

1. Primary open angle glaucoma with previous conjunctival cutting surgery including prior failed trabeculectomy.

2. Secondary glaucoma, e.g., neovascular, uveitic, or post-traumatic glaucoma.

• Age range: 21- 80 years old.
• Both genders and all ethnic groups comparable with the local community.
• Patients able and willing to cooperate with investigational plan.
• Patients able and willing to complete postoperative follow-up.
• Patients able to understand and willing to sign a written informed consent.

Exclusion Criteria

• Ocular infection within 14 days prior to prior to study entry.
• No light perception vision
• Previous cyclodestructive procedure.
• Children under 21 (see Inclusion of Children).
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Bascom Palmer Eye Institute

OTHER

Sponsor Role: collaborator

The New York Eye & Ear Infirmary

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

BioTissue Holdings, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hosam El Sheha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

BioTissue Holdings, Inc

Locations

Bascom Palmer Eye Institute

Miami, Florida, United States

New York Eye and Ear Infirmary

New York, New York, United States

Manhattan Eye, Ear, and Throat Hospital

New York, New York, United States

Harkness Eye Institute/ Columbia University

New York, New York, United States

Countries

United States

References

Anand A, Sheha H, Teng CC, Liebmann JM, Ritch R, Tello C. Use of amniotic membrane graft in glaucoma shunt surgery. Ophthalmic Surg Lasers Imaging. 2011 May-Jun;42(3):184-9. doi: 10.3928/15428877-20110426-01.

Reference Type: RESULT

PMID: 21563743 (View on PubMed)

Other Identifiers

R44EY019785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P010-2, Version 4

Identifier Type: -

Identifier Source: org_study_id