Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Repeatability of objective refraction
研究概览
简要总结
The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).
详细描述
Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to attend all scheduled study visits as required per protocol
- •22 years of age or older
- •Bilateral cataracts
- •Corneal astigmatism ≤ 1.25 D
- •Clear intraocular media other than cataract
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:
- •are currently pregnant,
- •have a positive urine pregnancy test result at V0,
- •intend to become pregnant during the study period,
- •are breast-feeding.
- •Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject
- •Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision
- •Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing
- •Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study
- •Systemic disease that could increase the operative risk or confound the outcome
- •Other protocol-specified exclusion criteria may apply
研究组 & 干预措施
FAIOL
Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject.
干预措施: Alcon Fluid Accommodating Intraocular Lens (Device)
FAIOL
Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject.
干预措施: Top Con Autorefractor (Other)
结局指标
主要结局
Repeatability of objective refraction
时间窗: Month 1 (post 2nd eye implant)
Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).
次要结局
未报告次要终点