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

Primary Purpose

Glaucomas, Pterygium

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

OculusGen Biodegradable Collagen Matrix Implant

About this trial

This is an interventional treatment trial for Glaucomas focused on measuring Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, Aeon Astron, ologen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: Known allergic reactions to collagen

Sites / Locations

Zhongshan Hospital Fudan University

Outcomes

Primary Outcome Measures

the effectiveness via the reduction of IOP and the incidence of pterygium recurrence

Secondary Outcome Measures

the safety via the incidence of complications and adverse events.

Full Information

NCT ID

NCT00320957

First Posted

May 1, 2006

Last Updated

May 23, 2008

Sponsor

Pro Top & Mediking Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT00320957

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Pro Top & Mediking Company Limited

4. Oversight

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucomas, Pterygium

Keywords

Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, Aeon Astron, ologen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

OculusGen Biodegradable Collagen Matrix Implant

Primary Outcome Measure Information:

Title

the effectiveness via the reduction of IOP and the incidence of pterygium recurrence

Time Frame

180 day

Secondary Outcome Measure Information:

Title

the safety via the incidence of complications and adverse events.

Time Frame

180 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fei Yuan, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

10937547

Citation

Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.

Results Reference

result

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

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