Status:
COMPLETED
MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Lead Sponsor:
iSTAR Medical
Conditions:
Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Diagnosis of glaucoma other than open angle glaucoma
- Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
- Neovascular glaucoma in the study eye
- Prior glaucoma surgery in the study eye
- Clinically significant corneal disease
- Patients with poor vision
Key Trial Info
Start Date :
November 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03374553
Start Date
November 25 2017
End Date
February 8 2021
Last Update
April 22 2022
Active Locations (3)
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1
Clínica Oftalmológica del Caribe
Barranquilla, Colombia
2
Maxivision Eye Hospital
Hyderabad, Telangana, India, 500034
3
Panama Eye Center
Panama City, Panama