OculusGen-Glaucoma Historical Control Study in Taiwan

Pro Top & Mediking

Status and phase: Terminated; Phase 3

Conditions: Glaucoma

Treatments: Device: OculusGen Biodegradable Collagen Matrix Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406822

Mediking 0502

Details and patient eligibility

About

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.

Full 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).

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)