A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Open Angle Glaucoma
- Sponsor
- iSTAR Medical
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation
Time Frame: 6 months after implantation surgery
Change of Medicated diurnal IOP \[mmHg\] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication