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

NCT ID: NCT06294613

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Vitreoretinal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vitreoretinal surgery supported by Luca System

Group Type: OTHER

vitreoretinal surgery

Intervention Type: DEVICE

Patients undergoing vitreoretinal surgery

Interventions

vitreoretinal surgery

Patients undergoing vitreoretinal surgery

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acusurgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Gent

Ghent, East Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Charlene Braun

Role: CONTACT

charlene.braun@acusurgical.com

+33663334352

Facility Contacts

Bart Leroy, PhD

Role: primary

Bart.Leroy@uzgent.be

+32 9 33 25791

Other Identifiers

CIV-23-07-043672

Identifier Type: -

Identifier Source: org_study_id