NCT04936256已完成不适用
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens
Gainesville Eye Associates1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Refractive Stability
研究概览
简要总结
The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).
详细描述
This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in both eyes.
- •Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option
- •Gender: Males and Females.
- •Age: 50 or older
- •Willing and able to provide written informed consent for participation in the study
- •Willing and able to comply with scheduled visits and other study procedures.
- •Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- •Potential postoperative visual acuity of (20/25 Snellen) or better in both eyes
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Irregular astigmatism (e.g. keratoconus)
- •Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
- •Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
- •Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- •Diabetic retinopathy
- •Macular pathology (e.g. ARMD, ERM)
- •History of retinal detachment
- •Any patient based on Barrett toric calculator that will have ≥ 0.75D residual astigmatism if Clareon® non-toric IOL is implanted
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity
- •Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating)
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Refractive Stability
时间窗: 3 months
Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)
次要结局
- Binocular Uncorrected Intermediate Visual Acuity(3 months)
- Binocular Uncorrected Distance Visual Acuity(3 months)
- Binocular Corrected Distance Visual Acuity(3 months)
- Binocular Distance-corrected Intermediate Visual Acuity(3 months)
- Binocular Defocus Curve(3 months)
研究者
研究点 (1)
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