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A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

A Multi-center, Prospective, Cohort Expansion Clinical Study Evaluating the Safety, Usability, Implantation Accuracy and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma (STAR VII Study)

NCT07009236•iSTAR Medical

View on ClinicalTrials.gov

Summary

This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females, 20 years of age or older
•2. Diagnosis of open angle glaucoma (OAG) in the study eye
•3. Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction (with IOL implantation) with MINIject implantation, a grade 2 angle is acceptable prior to cataract surgery so long is the angle becomes grade 3 or greater prior to MINIject implantation).
•4. Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a medication or inability to consistently access medication. Examples include but are not limited to prostaglandins, beta blockers, carbonic anhydrase inhibitors or alpha-2-agonists
•5. Minimal visual acuity in the study eye must be 35 letters EDTRS (20/200) or better and 50 letters ETDRS (20/100) or better in the fellow eye
•6. Maximal C/D ratio must be 0.9 in the study eye
•7. Subjects must be willing and able to follow study instructions and to return for scheduled study-related examinations
•8. Subjects must provide written informed consent prior to any study procedures
•9. Part 2 Only: Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
•10. Part 2 Only: The following intraoperative criteria following the IOL implantation need to be met in order for investigator to proceed with the investigational device placement:
+5 more criteria

Exclusion Criteria

•1. Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to Shaffer Angle Grading System in the study eye except for the situation described in inclusion criterion #3.
•2. Any eye surgery that was performed \< 90 days before Screening/Baseline visit in the study eye
•3. Diagnosis of diabetes mellitus with HbA1C \>7%
•4. Known or suspected allergy or hypersensitivity to medical silicone
•5. Allergy to fluorescein
•6. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant
•7. Central endothelial cell density (ECD) at Screening visit with a mean value \<1900 cells/mm2 or coefficient of variation (CV) of endothelium \>0.45 A variance of 5% less than this cell count is permitted if in the clinical judgement of the Investigator the potential benefit/risk to subject participation is favorable and the central corneal endothelial morphology is characterized as normal by the usual criteria of hexagonality, polymorphism, and polymegathism
•8. Anticipated need for ocular surgery or retinal laser procedure in the study eye
•9. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye,
•10. Pre-existing ocular or systemic pathology that, in the opinion of the investigator (reason to be specified on the case report form), is likely to cause post-operative complications following implantation
+14 more criteria

Locations (3)

Los Robles Vision d/b/a Centro Oftalmológico Robles

Santa Rosa de Copán, Honduras

Colchester General Hospital

Colchester, United Kingdom

St Thomas' Hospital

London, United Kingdom

Key Dates

Start Date

July 1, 2025

Primary Completion Date

December 1, 2027

Completion Date

March 1, 2028

Last Updated

June 6, 2025

Enrollment

ESTIMATED participants

Conditions

Glaucoma

Interventions

MIGS

DEVICE

Contacts

Florence Defresne, PhD

CONTACT

003210771251 florence.defresne@istar-medical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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