Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases

ConditionVitreoretinal Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorAcusurgical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

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.,

Trial design

Design model

Single group

Treatments tested in this trial

vitreoretinal surgery
Device
Patients undergoing vitreoretinal surgery

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: vitreoretinal surgery supported by Luca SystemOther 1 intervention

Trial outcomes

Primary outcomes

Safety Outcome

incidence and severity of investigational device-related (definitely or probably) adverse events, for all subjects treated with the study device (Safety Population).

Time frame

3 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acusurgical

Lead sponsor

Source ClinicalTrials.gov

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