- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406822
OculusGen-Glaucoma Historical Control Study in Taiwan
April 25, 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 Surgery
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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)
48
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
-
-
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Taipei, Taiwan, 10507
- Chang Gung Memorial Hospital -Taipei Branch
-
-
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
Subject inclusion criteria:
- Age 18 years or over.
- At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
- Subject able and willing to cooperate with investigation plan.
- Subject able and willing to complete postoperative follow-up requirements.
- Subject willing to sign informed consent form.
Subject exclusion criteria:
- Have allergic reactions to collagen
- Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication
- Normal tension glaucoma patient
- Subject has one eye received OculusGen™ implantation
- Subject who been diagnosed infection with the operation eye
- Subject with anterior chamber abnormality
- Subject with steroid glaucoma
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 |
---|---|
the effectiveness via the reduction of IOP
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: 180day
|
180day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Henry SL Chen, MD, Chang Gung Memorial Hospital-Taipei Branch
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, 2006
Study Registration Dates
First Submitted
October 10, 2006
First Submitted That Met QC Criteria
November 30, 2006
First Posted (Estimate)
December 4, 2006
Study Record Updates
Last Update Posted (Estimate)
May 5, 2008
Last Update Submitted That Met QC Criteria
April 25, 2008
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mediking 0502
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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