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

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Ologen

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Glaucoma Drainage implant no Ologen; The first group will use the routine technique for glaucoma drainage implant without placement of Ologen.
Active Comparator: 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.	Procedure: Ologen; Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effectiveness of ologen® Collagen Matrix in preventing intraocular pressure (IOP) spikes after Ahmed Glaucoma Valve Surgery (AGV-FP7)	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.	1 year

Collaborators and Investigators

• Sponsor: The New York Eye & Ear Infirmary
• Investigators: Principal Investigator: Noga Harizman, MD, NY Eye Ear

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2014
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 13.33