NCT05432245Enrolling by invitation
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
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
Source: ClinicalTrials.gov · Last updated 28 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Jun 2022
- Start date
- 18 Jan 2023
- Primary completion date
- Jul 2025
- Lead sponsor
- iSTAR Medical
- Diseases
- Glaucoma
- NCT number
- NCT05432245
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 18 Jan 2023 to the primary completion date, Jul 2025
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Presence of silicone oil in the study eye
- Individuals under tutorship or trusteeship
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital Coordinator of this site? Confirm its status | Colchester | United Kingdom | Unknown status |
| Princess Alexandra Eye Pavilion Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Panama Eye Center Coordinator of this site? Confirm its status | Panama City | Panama | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.