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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Open-angle Glaucoma Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type EXPERIMENTAL

Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)

Intervention Type DEVICE

The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No