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

A Prospective, Open, Multicentre Clinical Trial Analysing the Efficacy and Safety of Miniject (MINI SO627) in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications Using a Single Operator Delivery Tool

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03996200

Enrollment

Registered

2019-06-24

Start date

2019-07-23

Completion date

2022-02-10

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye, Glaucoma, Open-Angle

Keywords

glaucoma, medical device, MIGS, drainage device, eye, reduction IOP

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.

Interventions

DEVICEMINIject CS627 implant

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

MINIject SO627

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
medicated diurnal IOP	6 months post surgery	Change in medicated diurnal IOP

Countries

Colombia, India, Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026