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临床试验/NCT03226561
NCT03226561已完成不适用

Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation

Democritus University of Thrace2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
uNVC (25FC)

研究概览

简要总结

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

详细描述

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity

结局指标

主要结局

uNVC (25FC)

时间窗: 6 months

Uncorrected Near Vision Capacity at 25 Foot Candles

uNVC (4000K)

时间窗: 6 months

Uncorrected Near Vision Capacity at 4000 Kelvins

uNVC (3000K)

时间窗: 6 months

Uncorrected Near Vision Capacity at 3000 Kelvins

uNVC (50FC)

时间窗: 6 months

Uncorrected Near Vision Capacity at 50 Foot Candles

uNVC (6000K)

时间窗: 6 months

Uncorrected Near Vision Capacity at 6000 Kelvins

uNVC (75FC)

时间窗: 6 months

Uncorrected Near Vision Capacity at 75 Foot Candles

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Georgios Labiris

Associate Professor

Democritus University of Thrace

研究点 (2)

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