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

Phase 3

• Conditions: Cataract; Glaucoma
• Interventions: Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

• Registration Number: NCT00687791
• Lead Sponsor: Pro Top & Mediking Company Limited

Brief Summary

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.

Detailed Description

Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy)

Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-30
• Status Verified: 2008-06
• Study First Posted: 2008-06-02
• Last Update Submitted: 2008-06-17
• Last Update Posted: 2008-06-18
• Primary Completion: 2008-12
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery	20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2\> Phacotrabeculectomy is performed.3\> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor.

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to prove the effectiveness via the reduction of IOP.	180 days

Secondary Outcome Measures

Name	Time	Method
the secondary endpoint is to prove the safety via the reduction of complications.	180 days

Trial Locations

Locations (1)

Singapore Eye Research Institute; 🇸🇬 Singapore, Singapore