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

Sponsor

Pro Top & Mediking Company Limited (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00687791

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Glaucoma	Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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.	Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery Other Names: OculusGen (ologen™)

Arm

Intervention/Treatment

Experimental: 1

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.

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

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

Other Names:

OculusGen (ologen™)

Outcome Measures

Primary Outcome Measures

The primary endpoint is to prove the effectiveness via the reduction of IOP. [180 days]

Secondary Outcome Measures

the secondary endpoint is to prove the safety via the reduction of complications. [180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or over.
At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
Visually significant cataract with visual acuity of less than or equal to 6/12.
Subject able and willing to cooperate with investigation plan.
Subject willing to sign informed consent form.

Exclusion Criteria:

Known allergic reaction to collagen.
Subject is on Warfarin and discontinuation is not recommended.
Subject with normal tension glaucoma or aphakic glaucoma.
Subject with corneal disease.
Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
Ocular infection within 14 days prior to phacotrabeculectomy.
Pregnant or breast-feeding women.
Monocular subject.