OculusGen-Glaucoma Historical Control Study in Taiwan

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. Identifier: NCT00406822
Recruitment Status : Terminated (Terminated due to the change of supplier and sponsor)
First Posted : December 4, 2006
Last Update Posted : May 5, 2008
Information provided by:
Pro Top & Mediking Company Limited

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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: OculusGen Biodegradable Collagen Matrix Implant Phase 3

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  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Study Start Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Collagen

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00406822

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

Publications of Results: Identifier: NCT00406822     History of Changes
Other Study ID Numbers: Mediking 0502
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: May 5, 2008
Last Verified: June 2007

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases