Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in Beijing Remin Hospital

Pro Top & Mediking

Status and phase

Completed

Phase 3

Conditions

Glaucoma

Pterygium

Treatments

Device: OculusGen Biodegradable Collagen Matrix Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00321035

Mediking0501-1

Details and patient eligibility

About

The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.

Full description

ologen (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

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or over
Patient able to cooperate with study procedures and able to perform tests reliably
Patient willing to sign informed consent
Patient able and willing to complete postoperative follow-up requirements
Glaucoma：one/both eyes are affected by glaucoma
Pterygium： patient with pterygium

Exclusion criteria