Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital

Sponsor

Pro Top & Mediking Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT00320957

Collaborator

(none)

Enrollment

Location

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucomas Pterygium	Device: OculusGen Biodegradable Collagen Matrix Implant	Phase 3

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

the effectiveness via the reduction of IOP and the incidence of pterygium recurrence [180 day]

Secondary Outcome Measures

the safety via the incidence of complications and adverse events. [180 day]

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
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