A prospective, open-label, multi-center, study of the ACUSURGICAL luca system for treatment of vitreoretinal diseases

NCT ID NCT06294613

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Delta Hospital - CHIREC (Centre Hospitalier Interrégional Edith Cavell)

    NOT_YET_RECRUITING

    Brussels, 1160, Belgium

  • UZ Gent

    RECRUITING

    Ghent, East Flanders, 9000, Belgium

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