Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Photopic monocular CDVA, 400 cm
研究概览
简要总结
This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.
详细描述
This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
- •Desire for high post-operative spectacle independence
- •Willingness to cooperate with and complete all post-operative visits
- •Calculated lens power within +5.0 D and +34.0 D
- •Planned cataract removal by phacoemulsification
- •Clear intraocular media other that cataracts in both eyes
- •Potential post-operative visual acuity of 20/25 or better
- •Ability to comprehend and sign an informed consent
- •Signed informed consent
排除标准
- •More than 1.0 D of pre-operative corneal astigmatism
- •Expected post-operative astigmatism of more than 0.75 D
- •Mature/dense cataract which makes the pre-operative fundus examination difficult
- •Previous ocular surgery or trauma
- •Clinically significant irregular astigmatism
- •Choroidal hemorrhage
- •Microphthalmos
- •Severe corneal dystrophy
- •Medically controlled or uncontrolled glaucoma
- •Clinically significant macular/RPE changes
- •Concomitant severe eye disease
- •Severe optic nerve atrophy
- •Diabetic retinopathy, proliferative or macular edema
- •Amblyopia
- •Extremely shallow anterior chamber
- •Chronic sever uveitis
- •Pregnant or lactating
- •Previous retinal detachment
- •Previous corneal transplant
- •Concurrent participation in another drug or device investigation
- •May be expected to require other ocular surgery during the study
结局指标
主要结局
Photopic monocular CDVA, 400 cm
时间窗: 6 Months post second eye implantation
Photopic monocular CIVA, 60 cm
时间窗: 6 Months post second eye implantation
Photopic monocular CNVA, 40 cm
时间窗: 6 Months post second eye implantation
Rates of adverse events vs. ISO 11979-7:2018 SPE rate
时间窗: 6 Months post second eye implantation
次要结局
未报告次要终点