MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Not Applicable
Completed
- Conditions
- Open Angle Glaucoma
- Registration Number
- NCT03374553
- Lead Sponsor
- iSTAR Medical
- 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 asked to perform several examinations up to 24 months after surgery.
The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Reduction in medicated diurnal IOP 6 months after surgery DODT/SODT arm will be evaluated separately
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Clínica Oftalmológica del Caribe
🇨🇴Barranquilla, Colombia
Maxivision Eye Hospital
🇮🇳Hyderabad, Telangana, India
Panama Eye Center
🇵🇦Panama city, Panama
Clínica Oftalmológica del Caribe🇨🇴Barranquilla, Colombia