Status:
UNKNOWN
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
Lead Sponsor:
iSTAR Medical
Collaborating Sponsors:
International Drug Development Institute
Conditions:
Glaucoma, Open-Angle Glaucoma Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone sur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04517786
Start Date
January 15 2021
End Date
December 31 2023
Last Update
May 3 2023
Active Locations (2)
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1
Maxivision Super Speciality Eye Hospital
Hyderabad, India
2
Panama Eye Center
Panama City, Panama