CTRI/2018/03/012458
Completed
未知
A PROSPECTIVE, OPEN, MULTICENTRE CLINICAL TRIAL WITH ONE COHORT ANALYSING THE EFFICACY AND SAFETY OF MINIJECT IN PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS
iSTAR Medical SA0 sites10 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS
- Sponsor
- iSTAR Medical SA
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females, 18 years of age or older.
- •Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- •Grade 3 (open, 20\-35 degrees) or grade 4 (wide open, 35\-45 degrees) according to Shaffer Angle Grading System.
- •Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg \<\= IOP \<\= 35mmHg in the study eye at screening and baseline visits.
- •Patients must be willing and able to return for scheduled study\-related examinations.
- •Patients must provide written informed consent.
Exclusion Criteria
- •Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.
- •Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System.
- •Neovascular glaucoma in the study eye.
- •Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant.
- •Prior glaucoma surgery in the study eye. Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed \>\= 90 days before screening visit.
- •Visual field defect in the 10\-degree central field in the study eye.
- •Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery.
- •Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
- •Pre\-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.
- •Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
Outcomes
Primary Outcomes
Not specified
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