- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00321035
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in Beijing Remin Hospital
May 21, 2008 updated by: Pro Top & Mediking Company Limited
Study of the Safety and Effectiveness of the OculusGen Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100044
- Renmin Hospital of Beijing University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
Time Frame: 180 day
|
180 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the safety via the incidence of complications and adverse events.
Time Frame: 180 day
|
180 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiao-Xin Li, MD, Renmin Hospital of Beijing University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
May 1, 2006
First Submitted That Met QC Criteria
May 1, 2006
First Posted (Estimate)
May 3, 2006
Study Record Updates
Last Update Posted (Estimate)
May 22, 2008
Last Update Submitted That Met QC Criteria
May 21, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mediking0501-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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