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OpenTrials
Enrolling by Invitation

NCT Number: NCT05432245

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

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.

Enrolling by Invitation

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Key information

Conditions

Primary Open-Angle Glaucoma Cataract Eye Diseases Glaucoma Glaucoma, Open-Angle Lens Diseases Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Panama Eye Center, Panama City, Panama

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)

Device

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

Primary outcomes

  1. Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP

    Time frame: 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

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Official study title

A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis

Acronym: STAR-VI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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