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Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

Sponsored by Pro Top & Mediking Company Limited

About this trial

Last updated 17 years ago

Study ID

Mediking 0706

Status

Unknown status

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 17 years ago

What is this trial about?

The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy 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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Age 18 years or over.

2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.

3. Visually significant cataract with visual acuity of less than or equal to 6/12.

4. Subject able and willing to cooperate with investigation plan.

5. Subject willing to sign informed consent form.

No

Exclusion Criteria

1. Known allergic reaction to collagen.

2. Subject is on Warfarin and discontinuation is not recommended.

3. Subject with normal tension glaucoma or aphakic glaucoma.

4. Subject with corneal disease.

5. Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.

6. Ocular infection within 14 days prior to phacotrabeculectomy.

7. Pregnant or breast-feeding women.

8. Monocular subject.

Locations

Location

Status

Recruiting