NCT00477685
Completed
Not Applicable
Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Pro Top & Mediking Company Limited
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Preoperative and Postoperative Intraocular Pressure
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
- . 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.
- . 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.
- . 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Preoperative and Postoperative Intraocular Pressure
Time Frame: baseline and 90 days
The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.
Secondary Outcomes
- Number of Participants With Any Complications or Adverse Events.(180 day)
Study Sites (1)
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