OculusGen-Glaucoma Historical Control Study in Taiwan

This study has been terminated.
(Terminated due to the change of supplier and sponsor)
Sponsor:
Information provided by:
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00406822
First received: October 10, 2006
Last updated: April 25, 2008
Last verified: June 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00406822     History of Changes
Other Study ID Numbers: Mediking 0502
Study First Received: October 10, 2006
Last Updated: April 25, 2008
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014