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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the ACUSURGICAL Luca System in a prospective, open-label, single-center trial in Belgium to treat vitreoretinal diseases such as intravitreal hemorrhage and macular pucker. This study involves up to 15 participants undergoing vitreoretinal surgery, with only one eye per subject enrolled. The study focuses on evaluating the safety of this surgery system over a three-month period. Participants will undergo vitreoretinal surgery supported by the Luca System under general anesthesia. The study includes patients who are pseudophakic or aphakic, aged between 18 and 85 years, and who require vitrectomy to address specific eye conditions. The trial is monocentric and non-controlled, meaning all participants will receive the same surgical intervention without comparison groups. During the study, participants will have follow-up visits to monitor safety outcomes and assess visual function. Researchers will evaluate safety measures over three months after surgery. Participants must be able to comply with scheduled visits and have health insurance. The total participation duration is centered around surgery and post-operative monitoring within this timeframe.
CONDITIONS
Brief 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...
- Given written Informed Consent by subject
- Males or females aged 18 - 85 years, pseudophakic or aphakic
- Willing and able to comply with the schedule for follow-up visits
- Requiring vitrectomy under general anesthesia (conditions include vitreous hemorrhage treatment, diabetic retinopathy, vascular occlusion, adverse effect of anticoagulant therapy, macular pucker)
- Best Corrected Distance Visual Acuity (BCDVA) less than 7/10
- Deemed fit for robotic surgery per surgeons' assessment, including ability to undergo general anesthesia
- Beneficiary of health insurance
You will not qualify if you...
- Uncontrolled systemic disease that could increase operative risk or confound the outcome (autoimmune disease, uncontrolled hypertension, lung and heart disease impairing respiratory function, or other medical conditions as deemed by Clinical Investigator)
- Body Mass Index (BMI) over 30 kg/m8
- Axial length less than 22 mm or greater than 26 mm per ocular biometry
- Presence of clinically significant ocular inflammation or infection within 30 days before Preoperative Visit, such as cystoid macular edema (CME), uveitis
- Ocular conditions that may predispose to future complications or confound visual acuity results, including profound amblyopia (less than 1/10) or strabismus
- Ocular condition requiring additional surgical manipulation, such as membrane peeling or retinal neovascular formation
- Already vitrectomized on the study eye
- Presenting retinal detachment or retinal tear
- History of ocular trauma or post-traumatic vitreous hemorrhage
- Corneal scar preventing clear visualization of fundus
- Uncontrolled ocular pathology or degenerative disorder such as glaucoma with visual defect or uncontrolled intraocular pressure, uveitis, optic nerve damage
- Subjects without light perception
- Participation in other clinical studies
- Dependence on the Sponsor or Clinical Investigator
- Pregnant or lactating women based on self-declaration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 months
Participants undergo vitreoretinal surgery supported by the Luca System under general anesthesia followed by immediate post-operative care.
1 surgery visit and multiple post-operative follow-up visits
Trial Site Locations
Total: 1 location
1
UZ Gent
Ghent, East Flanders, Belgium, 9000
Actively Recruiting
Research Team
C
Charlene Braun
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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