MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Not Applicable

Completed

• Conditions: Glaucoma, Open-Angle; Glaucoma Eye
• Interventions: Device: MINIject CS627 implant

• Registration Number: NCT03996200
• Lead Sponsor: iSTAR Medical

Brief Summary

Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.

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 surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-07-23
• Primary Completion: 2020-02-14
• Study Completion: 2022-02-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MINIject CS627 implant	MINIject CS627 implant	MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.

Primary Outcome Measures

Name	Time	Method
medicated diurnal IOP	6 months post surgery	Change in medicated diurnal IOP

Trial Locations

Locations (3)

Clinica Oftalmologica del Caribe; 🇨🇴 Barranquilla, Colombia

Maxivision Eye Hospital; 🇮🇳 Hyderabad, Telangana, India

Panama Eye Center; 🇵🇦 Panama City, Panama