A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Best corrected distance ETDRS LogMar visual acuity
研究概览
简要总结
To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The subject will be masked to randomization assignment and will be unmasked at the completion of the study. Scheduled masked postoperative assessments will be performed by a masked examiner
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 22 years of age or older
- •Able to comprehend and provide written informed consent
- •Willing and able to comply with schedule for follow-up visits
- •Demonstrate sufficient cognitive awareness to comply with examination procedures
- •Other inclusion criteria specified in the protocol may apply.
排除标准
- •Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity
- •Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)
- •Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.)
- •Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)
- •Other exclusion criteria specified in the protocol may apply.
结局指标
主要结局
Best corrected distance ETDRS LogMar visual acuity
时间窗: 12 Months
Monocular photopic best corrected distance visual acuity (BCDVA)
Distance-corrected intermediate ETDRS LogMar visual acuity
时间窗: 12 Months
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
时间窗: 12 Months
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
Best corrected distance ETDRS LogMar visual acuity vs control
时间窗: 12 Months
Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
Defocus curve testing with ETDRS chart
时间窗: 12 Months
Monocular diopters of depth of focus (DOF)
次要结局
- Distance-corrected near ETDRS LogMar visual acuity(12 Months)
- Distance-corrected near ETDRS LogMar visual acuity vs control(12 Months)