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Clinical Trials/NCT06294613
NCT06294613RecruitingNot Applicable

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

Acusurgical3 sites in 1 country15 target enrollmentStarted: February 8, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
15
Locations
3
Primary Endpoint
Safety Outcome
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 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),
  • •BCDVA <7/10,
  • •Deemed fit for robotic surgery per surgeons' assessment, including ability to undergone local or 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) > 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.,
  • •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.

Arms & Interventions

vitreoretinal surgery supported by Luca System

Other

Intervention: vitreoretinal surgery (Device)

Outcomes

Primary Outcomes

Safety Outcome

Time Frame: 3 Months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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Study of the ACUSURGICAL Luca System for... | Clinical Trial