OculusGen-Glaucoma Historical Control Study in Taiwan
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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 |
- the effectiveness via the reduction of IOP [ Time Frame: 180 day ]
- the safety via the incidence of complications and adverse events. [ Time Frame: 180day ]
| Estimated Enrollment: | 48 |
| Study Start Date: | December 2006 |
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 |
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
Contacts and Locations| Taiwan | |
| Chang Gung Memorial Hospital -Taipei Branch | |
| Taipei, Taiwan, 10507 | |
| 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 June 18, 2013