Status:
ENROLLING_BY_INVITATION
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
Lead Sponsor:
iSTAR Medical
Conditions:
Primary Open-angle Glaucoma
Cataract
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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.
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 surge...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
January 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05432245
Start Date
January 18 2023
End Date
July 1 2025
Last Update
February 28 2025
Active Locations (4)
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1
Panama Eye Center
Panama City, Panama
2
Hospital Clínico San Carlos
Madrid, Spain
3
East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
Colchester, Essex, United Kingdom
4
Princess Alexandra Eye Pavilion
Edinburgh, United Kingdom