Status:
TERMINATED
OculusGen-Glaucoma Historical Control Study in Taiwan
Lead Sponsor:
Pro Top & Mediking Company Limited
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00406822
Start Date
December 1 2006
Last Update
May 5 2008
Active Locations (1)
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1
Chang Gung Memorial Hospital -Taipei Branch
Taipei, Taiwan, 10507