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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Ologen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |