Ologen (OculusGen)-Glaucoma Case Control Trial in India

Pro Top & Mediking

Status and phase

Completed

Phase 3

Conditions

Glaucoma

Treatments

Device: OculusGen Biodegradable Collagen Matrix Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00448929

Mediking 0702

OculusGen-2006-03-20

Details and patient eligibility

About

The purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents.

Full description

Study Objective: To determine the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant 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.
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 without antifibrotics.
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.

Enrollment

40 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 30 years or over.
No previous intraocular operative surgery
Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
Subject able and willing to cooperate with investigation plan.
Subject able and willing to complete postoperative follow-up requirements.
Subject willing to sign informed consent form.

Exclusion criteria

Known allergic reaction to porcine collagen.
Subject is on warfarin and discontinuation is not recommended.
Patient who has been diagnosed for one of following glaucoma: normal tension glaucoma, uveitic glaucoma, aphakia or pseudophakia glaucoma, neovascular glaucoma and other classified secondary glaucoma.
Participation in an investigational study during the 30 days proceeding trabeculectomy.
Ocular infection within 14 days prior to trabeculectomy.
Pregnant or breast-feeding women