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

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ClinicalTrials.gov Identifier: NCT02990143
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
The New York Eye & Ear Infirmary

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.

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Ologen Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effectiveness of Ologen® Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve Surgery (AGV-FP7)
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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.




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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990143


Contacts
Contact: Katy Tai 646-943-7925 eyeresearch@nyee.edu

Locations
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Meliza Unson, MD    212-979-4672    munson@nyee.edu   
Contact: Katy Tai    646-943-7925    eyeresearch@nyee.edu   
Principal Investigator: Noga Harizman, MD         
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Investigators
Principal Investigator: Noga Harizman, MD NY Eye Ear

Responsible Party: The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT02990143     History of Changes
Other Study ID Numbers: 13.33
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases