MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract (STAR-VI)

April 11, 2023 updated by: iSTAR Medical

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Panama
      • Panama City, Panama
        • Panama Eye Center
  • Spain
      • Madrid, Spain
        • Hospital Clinico San Carlos
  • United Kingdom
      • Edinburgh, United Kingdom
        • Princess Alexandra Eye Pavilion
    • Essex
      • Colchester, Essex, United Kingdom
        • East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
        • Contact:
          • Mahmoud/Chrys Radwan/Dimitriou, MD/MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iSTAR Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR VI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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