NCT00477685

Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Pro Top & Mediking Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. . Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure, 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 a historical controlled study. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. The allocation of subjects is non-randomized, and there is a single group for assignment. 3. . Follow-Up: This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. The further follow-up of subject after trial is continually tracked by the investigator.

Detailed description

ologen collagen matrix is applied for the phacotrabec surgery.

Conditions

• Glaucoma
• Cataract

Interventions

Type	Name	Description
DEVICE	OculusGen Biodegradable Collagen Matrix Implant	OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2007-05-24
• Last updated: 2017-08-14
• Results posted: 2012-03-29

Locations

1 site across 1 country: India