OculusGen-Glaucoma Historical Control Study in Taiwan

Study of the Safety and Effectiveness of the OculusGen Collagen Matrix Implant as an Aid in Glaucoma Surgery

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406822

Enrollment

Registered

2006-12-04

Start date

2006-12-31

Completion date

Unknown

Last updated

2008-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma, collagen matrix, OculusGen, trabeculectomy, tissue engineering

Brief summary

The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

Detailed description

OculusGen® Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Interventions

DEVICEOculusGen Biodegradable Collagen Matrix Implant

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subject inclusion criteria: 1. Age 18 years or over. 2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy. 3. Subject able and willing to cooperate with investigation plan. 4. Subject able and willing to complete postoperative follow-up requirements. 5. Subject willing to sign informed consent form. Subject

Exclusion criteria

1. Have allergic reactions to collagen 2. Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication 3. Normal tension glaucoma patient 4. Subject has one eye received OculusGen™ implantation 5. Subject who been diagnosed infection with the operation eye 6. Subject with anterior chamber abnormality 7. Subject with steroid glaucoma

Design outcomes

Primary

Measure	Time frame
the effectiveness via the reduction of IOP	180 day

Secondary

Measure	Time frame
the safety via the incidence of complications and adverse events.	180day

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026