At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of primary or secondary open angle glaucoma
- ✓Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) angle classification
- ✓Glaucoma not adequately controlled by topical medications
- ✕Diagnosis of glaucoma other than open angle glaucoma
- ✕Grade 2, grade 1, or grade 0 angles by Shaffer classification
- ✕Neovascular glaucoma in the study eye
- ✕Prior glaucoma surgery in the study eye
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating MINIject implant for Open Angle Glaucoma. Completed, enrolled 26 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.