Vitreoretinal Disease
Conditions
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.
Interventions
DEVICEvitreoretinal surgery
Patients undergoing vitreoretinal surgery
Sponsors
Acusurgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome | 3 Months | incidence and severity of investigational device-related (definitely or probably) adverse events, for all subjects treated with the study device (Safety Population). |
Countries
Belgium
Contacts
CONTACTCharlene Braun
Outcome results
None listed