A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of V… (NCT06294613) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
Belgium15 participantsStarted 2024-02-08
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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,
* Alr…