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

Launched by ACUSURGICAL · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical system called the ACUSURGICAL Luca System, which aims to treat specific eye conditions known as vitreoretinal diseases, including issues like bleeding inside the eye (intravitreal hemorrhage) and macular pucker (a condition where the retina becomes wrinkled). The trial is being conducted in Belgium and is looking to enroll up to 7 participants who are undergoing surgery for these conditions. To be eligible, participants must be between 18 and 85 years old, have certain visual impairments, and be in good enough health to undergo surgery under general anesthesia.

If you or a family member are considering joining the trial, you should know that only one eye can be included in the study, and participants will need to agree to regular follow-up visits after the surgery. The trial is currently recruiting, and it’s essential to meet specific health criteria to ensure safety during the procedure. Overall, this study aims to gather information about the effectiveness and safety of the Luca System in treating these eye conditions.

Gender

ALL

Eligibility criteria

• 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.