The Effectiveness of Ologen® Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve Surgery (AGV-FP7)

NCT ID: NCT02990143

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-15
• Study Completion Date: 2017-12-15

Brief Summary

The purpose of this study is to investigate whether placing Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

Detailed Description

Uncontrolled glaucoma may require surgical intervention. Glaucoma drainage implants such as AGV-FP7 are in wide use upon glaucoma and comprehensive surgeons. The success of aqueous shunt surgery depends on the formation and maintenance of a thin permeable capsule around the posterior plate of the aqueous shunt. Encapsulated bleb formation, where the capsule is thick and elevated, is a common cause of drainage failure in the early post-operative period. This finding is usually accompanied by elevated intraocular pressure (IOP), which requires additional intervention, often surgical and therefore reduces the success rate of the initial surgery.

Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery. This device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.

This study is to investigate whether placing Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

Conditions

Glaucoma

Study Design

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

Study Groups

Glaucoma Drainage implant no Ologen

The first group will use the routine technique for glaucoma drainage implant without placement of Ologen.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Glaucoma Drainage implant with Ologen

the second group will undergo the same procedure but will have the Ologen placed and secured over the plate of the AGV-FP7, under the conjunctiva, during the surgery.

Group Type: ACTIVE_COMPARATOR

Ologen

Intervention Type: PROCEDURE

Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.

Interventions

Ologen

Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years.
• Uncontrolled treated glaucoma requiring AGV-FP7 surgery.
• Subject must be able and willing to cooperate with investigation plan.
• Subject must be able and willing to complete postoperative follow-up requirements
• Subject must be willing to sign informed consent form

Exclusion Criteria

• Known allergic reaction to porcine collagen
• History of uveitis
• Corneal opacity or irregularity, preventing visualization of patency of tip of tube or accurate applanation
• History of scleral buckle

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The New York Eye & Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noga Harizman, MD

Role: PRINCIPAL_INVESTIGATOR

NY Eye Ear

Locations

New York Eye and Ear Infirmary

New York, New York, United States

Countries

United States

Other Identifiers

13.33

Identifier Type: -

Identifier Source: org_study_id