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

iSTAR Medical21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma, Open-Angle Glaucoma Eye

Interventions

MINIject CS627 implantDEVICE

MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool. The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Maxivision Super Speciality Eye Hospital

Hyderabad, India

Panama Eye Center

Panama City, Panama

Outcomes

Primary Outcomes

Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up

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.

Time frame: 6 month post surgey

Data from ClinicalTrials.gov

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