Actively Recruiting
A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
Led by Acusurgical · Updated on 2025-01-30
15
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, interventional, open-label, non-controlled, monocentric study in Belgium of Luca, of up to 15 evaluable subjects, undergoing vitreoretinal surgery to treat intravitreal hemorrhage and macular pucker. Only one eye per subject can be enrolled.
CONDITIONS
Official Title
A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Male or female aged 18 to 85 years, pseudophakic or aphakic
- Willing and able to follow the scheduled follow-up visits
- Requires vitrectomy under general anesthesia for vitreous hemorrhage treatment or macular pucker
- Best corrected distance visual acuity less than 7/10
- Considered fit for robotic surgery by surgeon, including ability to undergo general anesthesia
- Has health insurance coverage
You will not qualify if you...
- Uncontrolled systemic diseases increasing operative risk or affecting outcomes (autoimmune disease, uncontrolled hypertension, lung or heart disease, or other conditions per investigator)
- Body mass index over 30 kg/m²
- Eye axial length less than 22 mm or greater than 26 mm by ocular biometry
- Significant ocular inflammation or infection within 30 days before surgery (e.g., cystoid macular edema, uveitis)
- Ocular conditions increasing risk of complications or affecting vision outcomes, including severe amblyopia or strabismus
- Known need for additional surgical procedures like membrane peeling or retinal neovascular cutting
- Previous vitrectomy on the study eye
- Retinal detachment or retinal tear present
- History of eye trauma or post-traumatic vitreous hemorrhage
- Corneal scarring that blocks fundus visualization
- Uncontrolled ocular diseases such as glaucoma with visual defects or uncontrolled intraocular pressure, uveitis, optic nerve damage
- No light perception in the study eye
- Participation in other clinical studies
- Dependency on the sponsor or clinical investigator
- Pregnant or breastfeeding women, based on self-report
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ Gent
Ghent, East Flanders, Belgium, 9000
Actively Recruiting
Research Team
C
Charlene Braun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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