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Clinical Trials in Spain / NCT05432245
Enrolling by invitation Not applicable

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

NCT05432245 · tracked via the Priya Life Science Spain tracker
Sponsor
iSTAR Medical
Phase
Not applicable
Started
2023-01-18
Last updated
2025-02-28

Condition(s) studied

Primary Open-angle GlaucomaCataract

Investigational drug(s) / intervention(s)

Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)

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.

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Panama Eye Center Panama City Panama
Hospital Clínico San Carlos Madrid Spain
East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital Colchester Essex
Princess Alexandra Eye Pavilion Edinburgh United Kingdom

More iSTAR Medical trials in Spain

STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program Active, not recruiting
MINIject Global Long-Term Follow-up Study Active, not recruiting

Other trials for the same condition

Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic Recruiting
A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery Recruiting
Toric Performance And Constant Evaluation Recruiting
Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design Enrolling by invitation
Visual Performance of Clareon Vivity and PureSee IOL Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05432245 on ClinicalTrials.gov ↗ ← All trials in Spain