NCT00472810

Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pro Top & Mediking Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

Detailed description

1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy with mitomycin-C. 3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.

Conditions

• Glaucoma
• Trabeculectomy

Interventions

Type	Name	Description
DEVICE	ologen collagen matrix in glaucoma filtering surgery	If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
DRUG	MMC in glaucoma filtering surgery	If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-05-01
• First posted: 2007-05-14
• Last updated: 2011-10-07

Locations

1 site across 1 country: Pakistan