Vitreoretinal DiseaseNCT06294613
Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
A study testing vitreoretinal surgery in people with Vitreoretinal Disease, run by Acusurgical at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vitreoretinal Disease
- What is being tested?
- vitreoretinal surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesBelgium
- Study dates
- 8 Feb 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Delta Hospital - CHIREC (Centre Hospitalier Interrégional Edith Cavell)
Brussels, 1160
Fanny Nerincks, Dr, +32 2 434 81 09, fanny.nerinckx@chirec.be
- Recruiting
UZ Gent
Ghent, East Flanders, 9000
Bart Leroy, PhD, +32 9 33 25791, Bart.Leroy@uzgent.be
About this study
Official title: A Prospective, Open-label, Multi-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
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.
- Conditions
- Vitreoretinal Disease
- Being tested
- vitreoretinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitreoretinal surgeryDevice
Patients undergoing vitreoretinal surgery
| Study group | Role | What they receive |
|---|---|---|
| vitreoretinal surgery supported by Luca System | Other | Not described Receives: Device: vitreoretinal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome
incidence and severity of investigational device-related (definitely or probably) adverse events, for all subjects treated with the study device (Safety Population).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start8 Feb 2024
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acusurgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294613
- Sponsor's protocol ID
- CIV-23-07-043672
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multi-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
- ClinicalTrials.gov ID
- NCT06294613
- Acronym / sponsor ID
- CIV-23-07-043672
- Conditions
- Vitreoretinal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- AcusurgicalIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vitreoretinal surgery supported by Luca System | Other | Device: vitreoretinal surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitreoretinal surgeryPatients undergoing vitreoretinal surgery | Device | vitreoretinal surgery supported by Luca System |
Primary outcome
Safety Outcome
Time frame: 3 Months
incidence and severity of investigational device-related (definitely or probably) adverse events, for all subjects treated with the study device (Safety Population).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitreoretinal surgery in people with Vitreoretinal Disease, run by Acusurgical at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlene Braun (+33663334352, charlene.braun@acusurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.