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Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

NCT00477685 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2017-08-14

Study results available
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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.

Conditions

Interventions

DEVICE

OculusGen Biodegradable Collagen Matrix Implant

OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Sponsors & Collaborators

  • Pro Top & Mediking Company Limited

    lead INDUSTRY

Principal Investigators

  • SPS Grewal, MD · Grewal Eye Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00477685 on ClinicalTrials.gov