NCT06294613招募中不适用
A Prospective, Open-label, Multi-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Acusurgical
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Safety Outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
vitreoretinal surgery supported by Luca System
Other
干预措施: vitreoretinal surgery (Device)
结局指标
主要结局
Safety Outcome
时间窗: 3 Months
incidence and severity of investigational device-related (definitely or probably) adverse events, for all subjects treated with the study device (Safety Population).
次要结局
未报告次要终点
研究者
研究点 (3)
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