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.
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),
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.,