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OculusGen-Glaucoma Historical Control Study in Taiwan

This study has been terminated.
(Terminated due to the change of supplier and sponsor)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406822
First Posted: December 4, 2006
Last Update Posted: May 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pro Top & Mediking Company Limited
  Purpose
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.

Condition Intervention Phase
Glaucoma Device: OculusGen Biodegradable Collagen Matrix Implant Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Safety and Effectiveness of the OculusGen Collagen Matrix Implant as an Aid in Glaucoma Surgery

Resource links provided by NLM:


Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:
  • the effectiveness via the reduction of IOP [ Time Frame: 180 day ]

Secondary Outcome Measures:
  • the safety via the incidence of complications and adverse events. [ Time Frame: 180day ]

Estimated Enrollment: 48
Study Start Date: December 2006
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subject inclusion criteria:

  1. Age 18 years or over.
  2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
  3. Subject able and willing to cooperate with investigation plan.
  4. Subject able and willing to complete postoperative follow-up requirements.
  5. Subject willing to sign informed consent form.

Subject exclusion criteria:

  1. Have allergic reactions to collagen
  2. Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication
  3. Normal tension glaucoma patient
  4. Subject has one eye received OculusGen™ implantation
  5. Subject who been diagnosed infection with the operation eye
  6. Subject with anterior chamber abnormality
  7. Subject with steroid glaucoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406822


Locations
Taiwan
Chang Gung Memorial Hospital -Taipei Branch
Taipei, Taiwan, 10507
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: Henry SL Chen, MD Chang Gung Memorial Hospital-Taipei Branch
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00406822     History of Changes
Other Study ID Numbers: Mediking 0502
First Submitted: October 10, 2006
First Posted: December 4, 2006
Last Update Posted: May 5, 2008
Last Verified: June 2007

Keywords provided by Pro Top & Mediking Company Limited:
Glaucoma
collagen matrix
OculusGen
trabeculectomy
tissue engineering

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases