MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract

NCT05432245 · tracked via the Priya Life Science UK tracker

Sponsor

iSTAR Medical

Phase

Not applicable

Started

2023-01-18

Last updated

2025-02-28

Condition(s) studied

Primary Open-angle GlaucomaCataract

Investigational drug(s) / intervention(s)

Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)

Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS): The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.

Study summary

The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Diagnosis of primary open angle glaucoma (POAG) in the study eye * Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation * Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication * Patient must provide written informed consent to participate Exclusion Criteria: * Known or suspected allergy or hypersensitivity to medical silicone * Allergy to fluorescein * Presence of silicone oil in the study eye * Individuals under tutorship or trusteeship * Patient has a condition such that his / her ability to provide personal informed consent is compromised

Primary outcome measure(s)

Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP — 6 months
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications

Trial sites (4)

Facility	City	Region
Panama Eye Center	Panama City	Panama
Hospital Clínico San Carlos	Madrid	Spain
East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital	Colchester	Essex
Princess Alexandra Eye Pavilion	Edinburgh	United Kingdom

More iSTAR Medical trials in the UK

Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma. Active, not recruiting

A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma Recruiting

STAR-LIFE: a Post-market Registry on MINIject Active, not recruiting

Other trials for the same condition

Toric Performance And Constant Evaluation Recruiting

Surgical Procedure Efficiency Evaluation stuDy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05432245 on ClinicalTrials.gov ↗ ← All trials in the UK