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

Phase 3

Completed

• Conditions: Glaucoma; Pterygium

• Registration Number: NCT00320762
• Lead Sponsor: Pro Top & Mediking Company Limited

Brief Summary

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

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 brings a certain pressure press on the top of the scleral flap which makes the dynamic balance for the aqueous system 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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Primary Completion: 2007-12
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-21
• Last Update Posted: 2008-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Aged 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 eye(s) is/are affected by glaucoma
• Pterygium: patient with pterygium

Exclusion Criteria

• Known allergic reactions to collagen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence	180 day

Secondary Outcome Measures

Name	Time	Method
the safety via the incidence of complications and adverse events.	180 day

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, China