N/A
Completed N=26
MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Source: ClinicalTrials.gov NCT03193736 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Feb 2021
Primary outcomePrimary: Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation — -8.95 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation |
-8.95 | — |
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
Data sourced from ClinicalTrials.gov (NCT03193736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.