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

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

Sponsors

Lead Sponsor: Pro Top & Mediking Company Limited

Source 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

Overall Status Unknown status
Start Date 2007-12-01
Completion Date 2008-12-01
Primary Completion Date 2008-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The primary endpoint is to prove the effectiveness via the reduction of IOP. 180 days
Secondary Outcome
Measure Time Frame
the secondary endpoint is to prove the safety via the reduction of complications. 180 days
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Description: Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Arm Group Label: 1

Other Name: OculusGen (ologen™)

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Aung Tin, PhD MD Study Chair Singapore Eye Research Institute
Overall Contact

Last Name: Aung Tin, PhD MD

Phone: +65-62277255

Email: [email protected]

Location
Facility: Status: Singapore Eye Research Institute
Location Countries

Singapore

Verification Date

2008-06-01

Responsible Party

Name Title: Assoc. Prof. Aung Tin

Organization: Singapore Eye Research Institute

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: 1

Type: Experimental

Description: 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.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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