A prospective, open-label, multi-center, study of the ACUSURGICAL luca system for treatment of vitreoretinal diseases
NCT ID NCT06294613
First seen Sep 10, 2026 · Last updated Sep 10, 2026
Summary
Prospective, interventional, open-label, non-controlled, multicentric 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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Delta Hospital - CHIREC (Centre Hospitalier Interrégional Edith Cavell)
NOT_YET_RECRUITINGBrussels, 1160, Belgium
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UZ Gent
RECRUITINGGhent, East Flanders, 9000, Belgium
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