MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04517786
• Lead Sponsor: iSTAR Medical

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 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: 2020-08-14
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-18
• Study Start: 2021-01-15
• Primary Completion: 2022-05-16
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

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
Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up	6 month post surgey	The primary endpoint of the study is the reduction in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up compared to medicated or unmedicated (without washout) diurnal IOP at baseline visit.

Trial Locations

Locations (2)

Panama Eye Center; 🇵🇦 Panamá, Panama

Maxivision Super Speciality Eye Hospital; 🇮🇳 Hyderabad, India