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
Sponsored by
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
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
No
Eligibility Criteria
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
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
Learn more about this trial
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital
We'll reach out to this number within 24 hrs