MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool (NCT04517786) | Clinical Trial Compass
UnknownNot Applicable
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
India, Panama21 participantsStarted 2021-01-15
Plain-language summary
The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 or grade 4 according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg \< IOP \< 35 mmHg in the study eye at baseline visit.
Exclusion Criteria:
* Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
* Neovascular glaucoma in the study eye.
* Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
* Prior glaucoma surgery in the study eye.
What they're measuring
1
Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up