Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

Completed

• Conditions: Cataract; Glaucoma
• Interventions: Device: OculusGen Biodegradable Collagen Matrix Implant

• Registration Number: NCT00477685
• Lead Sponsor: Pro Top & Mediking Company Limited

Brief 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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2011-10-24
• Results First Submitted QC: 2012-02-29
• Results First Posted: 2012-03-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-01
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OculusGen Collagen Matrix	OculusGen Biodegradable Collagen Matrix Implant	OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Primary Outcome Measures

Name	Time	Method
Preoperative and Postoperative Intraocular Pressure	baseline and 90 days	The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Any Complications or Adverse Events.	180 day	Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.

Trial Locations

Locations (1)

Grewal Eye Institute; 🇮🇳 Chandigarh, India