A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases

Prospective, interventional, open-label, non-controlled, monocentric 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 Overview

• Status: Recruiting
• Conditions: Vitreoretinal Disease
• Intervention / Treatment: Device: vitreoretinal surgery

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlene Braun; Phone Number: +33663334352; Email: charlene.braun@acusurgical.com

Study Locations

• Belgium
  • East Flanders
    • Gent, East Flanders, Belgium, 9000
      • Recruiting
      • UZ Gent
      • Contact: Bart Leroy, PhD; Phone Number: +32 9 33 25791; Email: Bart.Leroy@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 vitrectomy under 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 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) > 30,
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: vitreoretinal surgery supported by Luca System	Device: vitreoretinal surgery; Patients undergoing vitreoretinal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome	incidence and severity of investigational device-related (definitely or probably) adverse events, for all subjects treated with the study device (Safety Population).	3 Months

Collaborators and Investigators

• Sponsor: Acusurgical

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Hemorrhage; Epiretinal Membrane
• Other Study ID Numbers: CIV-23-07-043672

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No