Tests MINIject implant with cataract surgery for glaucoma and cataract
Tests a MINIject eye implant with cataract surgery in adults with glaucoma.
Plain-language title generated from the registry record
Registry title: MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
Key facts
- Where
- Madrid, SpainSee the site
Where in Spain
- Hospital Clínico San CarlosMadrid, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iSTAR Medical
- Trial code
- NCT05432245
- Record updated
- 28 February 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Known or suspected allergy or hypersensitivity to medical silicone; Allergy to fluorescein; Patient has a condition such that his / her ability to provide personal informed consent is compromised; Presence of silicone oil in the study eye; Individuals under tutorship or trusteeship.