Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 glaucoma cases, the efficacy being the primary objective and the safety being the secondary.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aeon Astron Europe B.V.
• Collaborators: Glaucoma Associates of New York; Robert Ritch, MD, LLC.; The New York Eye & Ear Infirmary
• Treatments: Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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