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

Primary Purpose

Glaucoma, Pterygium

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
OculusGen Biodegradable Collagen Matrix Implant
Sponsored by
Pro Top & Mediking Company Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Hospital

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

First Posted
May 1, 2006
Last Updated
May 21, 2008
Sponsor
Pro Top & Mediking Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00320762
Brief Title
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Beijing 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
December 2007 (Actual)
Study Completion Date
undefined (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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Pterygium
Keywords
Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, Aeon Astron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

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
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Dai, MD
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
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 Beijing Hospital

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