Status:
COMPLETED
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
Lead Sponsor:
Aeon Astron Europe B.V.
Collaborating Sponsors:
The New York Eye & Ear Infirmary
Robert Ritch, MD, LLC.
Conditions:
Glaucoma
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated ...
Detailed Description
"ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in trabeculectomy, its sporous matrix modulates th...
Eligibility Criteria
Inclusion
- Age \> 30 years (inclusive)
- Uncontrolled treated glaucoma requiring trabeculectomy
- 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
- Known allergic reaction to MMC or porcine collagen
- Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery
- Prior cataract unless clear corneal incision
- Previous conjunctival or strabismus surgery
- Participation in an investigational study during 30 days prior to trabeculectomy
- Ocular infection within 14 days prior to trabeculectomy
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01440751
Start Date
September 1 2011
End Date
December 1 2015
Last Update
November 1 2017
Active Locations (8)
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1
VoldVision-Holf Eye Clinic
Rogers, Arkansas, United States, 72756
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
3
Institue of Ophthalmology and Visual Science
Newark, New Jersey, United States, 07103
4
Glaucoma Associates of New York
New York, New York, United States, 10003