CT Lucia 601 IOL Implantation in the Sulcus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- safety of the CT Lucia 601 IOL in the sulcus
研究概览
简要总结
To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus
详细描述
The purpose of the study is to collect data that are parameters of post-IOL implantation safety:
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Questionnaire on subjective quality of vision
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Centration and anteroposterior position of the IOL (using biometry)
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Presence and quantification of any inflammation or pigment present in the anterior chamber (flare meter)
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Refractive outcome, with calculation of customized A-constant of the CT Lucia 601 IOL in-the-sulcus and quantification of higher-order aberrations (HOA)
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General safety-parameters:
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Visual acuity
-
Intra-ocular pressure
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Presence of macular edema or retinal nerve fiber layer (RNFL) thinning (SD-OCT)
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Any adverse ophthalmic events
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with an implantation of a CT Lucia 601 lens for different reasons:
- •During vitrectomy to treat a complicated cataract surgery and had the implantation of a CT Lucia 601 IOL in the sulcus or patients
- •During phaco surgery with a posterior capsule tear that necessitated the implantation of the implant lens in the sulcus
- •Explantation of an in-the-bag lens and implantation of a CT Lucia 601 as replacement lens (e.g. to treat opacification of the implant lens or intolerance of the implant lens).
- •Age : > 18 years
- •Signed informed consent
- •Preoperative myopia less than 10 diopters
- •Implantation of the CT Lucia IOL at least six months earlier
排除标准
- •History of uveitis
- •Ocular pathology or history that could influence the biometry of the effective lens position, such as ocular trauma with zonulolysis, congenital iris- or lens defects etc.
- •Any eye condition influencing the lens position (to be specified) according to the investigator
结局指标
主要结局
safety of the CT Lucia 601 IOL in the sulcus
时间窗: 2019-2020
determine whether the CT Lucia 601 IOL can be used safely in the sulcus
次要结局
未报告次要终点