OculusGen-Glaucoma Historical Control Study in Taiwan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Glaucoma

Keywords

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Glaucoma collagen matrix OculusGen trabeculectomy tissue engineering

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OculusGen Biodegradable Collagen Matrix Implant

Intervention Type DEVICE

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Henry SL Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital-Taipei Branch

Locations

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Chang Gung Memorial Hospital -Taipei Branch

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.

Reference Type RESULT

PMID: 10937547 (View on PubMed)

Other Identifiers

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Mediking 0502

Identifier Type: -

Identifier Source: org_study_id