Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C

• Status: Completed
• Trial end date: 2017-03-30
• Target enrollment: 0
• Participant gender: All

Summary

1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.

2. Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.

3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Lublin
• Collaborator: Aeon Astron Europe B.V.
• Treatments: Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Cataract

• Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication

Exclusion Criteria:

• Difficulty in reading or speaking Polish

• Previous ocular surgery

• Pregnant and breastfeeding women

• Angle closure glaucoma

• Secondary glaucoma except pseudoexfoliation glaucoma

• Ocular diseases with excessive scarring

• Allergy to collagen or Mitomycin C