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

Not Applicable

• Conditions: Cataract; Primary Open-angle Glaucoma
• Interventions: Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)

• Registration Number: NCT05432245
• Lead Sponsor: iSTAR Medical

Brief 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.

Detailed Description

The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.

Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Study Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Study Start: 2023-01-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)	-

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (4)

East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital; 🇬🇧 Colchester, Essex, United Kingdom

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Panama Eye Center; 🇵🇦 Panama City, Panama

Princess Alexandra Eye Pavilion; 🇬🇧 Edinburgh, United Kingdom