Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany

• Status: Unknown status
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aeon Astron Europe B.V.
• Treatments: Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Age 18 years or over

• Uncontrolled open-angle glaucoma

• Subject is willing to sign informed consent

• Subject is able and willing to complete post-operative follow-up requirements

Exclusion Criteria:

• Inflammatory eye diseases

• Angle-closure glaucoma

• Secondary glaucoma with anatomical malformations of the eye

• Subjects having single functional eye

• Previous conjunctival surgery

• Known allergic reactions to ingredients of ologen Collagen Matrix

• Excessive myopia (axial length (AL)> 27 mm or more than -10 diopters)

• Previous vitrectomy eye surgery

• Subjects do not consent to participate