Using the ACUSURGICAL Luca System for treating eye diseases
Official title: A Prospective, Open-label, Multi-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
Run by Acusurgical · NCT06294613 · Data updated 2026-11-12
This study is testing a new robotic system for eye surgery to see if it can safely and effectively help people with certain eye conditions like bleeding in the eye and macular pucker.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Acusurgical Industry-sponsored |
| Locations | 2 sites (Ghent, East Flanders and 1 other locations) |
| Status | Recruiting |
| Started | February 8, 2024 |
| Main results expected | March 2027 |
| Study ends | May 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT06294613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males or females aged 18 to 85 years who require vitrectomy for specific vitreoretinal conditions and are fit for robotic surgery.
✕Probably not a fit
Patients with uncontrolled systemic diseases or specific ocular measurements that fall outside the study's criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the ACUSURGICAL Luca System in a prospective, open-label format for patients undergoing vitreoretinal surgery to address conditions such as intravitreal hemorrhage and macular pucker. Conducted at a single center in Belgium, the study aims to enroll up to 15 participants, with only one eye per subject being treated. Participants will undergo vitrectomy under general anesthesia, and the study will assess the safety and efficacy of this robotic surgical approach.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes for patients with vitreoretinal diseases.
How similar studies have gone: While this approach is novel, similar robotic surgical interventions have shown promise in other studies, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 vitreoretinal surgery under local or general anesthesia (conditions include vitreous hemorrhage treatment (with potential clinical conditions including: diabetic retinopathy, vascular occlusion, adverse effect of anticoagulant therapy), macular pucker), * BCDVA \<7/10, * Deemed fit for robotic surgery per surgeons' assessment, including ability to undergone local or general anesthesia, * Beneficiary of health insurance. Exclusion Criteria: * Uncontrolled systemic disease that could increase the operative risk or confound the outcome (autoimmune disease, uncontrolled hypertension, lung and heart disease impairing respiratory function, or any other medical condition as deemed by the Clinical Investigator), * BMI (kg/m²) \> 40, * Axial length \<22 or \>26 mm per ocular biometry, inclusive, * Presence of clinically significant ocular inflammation or infection within 30 days of Preop Visit, such as CME, uveitis, etc., * Ocular condition, that in the opinion of the Clinical Investigator, may predispose for future complications or confound visual acuity results, including profound amblyopia (\<1/10) or strabismus, * Ocular condition presenting associated pathology likely to require additional surgical manipulation, such as known need for membrane peeling, or retinal neovacular formation to be cut, * Already vitrectomized on the study eye, * Presenting retinal detachment or retinal tear, * History of ocular traumatism; post-traumatic vitreous hemorrhage, * Corneal scar preventing clear visualization of fundus, * Any associated ocular pathology or ocular degenerative disorder that is uncontrolled such as glaucoma with clinical visual defect or IOP not controlled by medical treatment, uveitis, optic nerve damage, * Subjects without light perception, * Subject participating in other clinical studies, * Subject being dependent on the Sponsor or Clinical Investigator, * Pregnant or lactating women, based on self-declaration.
Where it's running
-
UZ Gent
Ghent, East Flanders, Belgium Recruiting -
Delta Hospital - CHIREC (Centre Hospitalier Interrégional Edith Cavell)
Brussels, Belgium Not yet recruiting
Study contacts
- Study coordinator: Charlene Braun
- Email: charlene.braun@acusurgical.com
- Phone: +33663334352
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Analyzing vitreous fluid to identify biomarkers in retinal diseases
This study is trying to find specific markers in the eye fluid of people with different retinal diseases to help understand these conditions better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.