Impact of Artificial Lighting on Visual Acuity After Presbyopia Correction With an Extended Depth of Focus Intraocular Lens: Introduction of a Modified Luminous Efficiency Function V(λ)'
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Minimum Required Illuminance Level (MRIL)
研究概览
简要总结
Primary objective of this study is to introduce a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients who underwent pseudophakic presbyopic correction with extended-depth of focus (EDOF) intraocular lenses (IOLs) implantations.
详细描述
Present study aims to identify in which degree EDOF IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following pseudophakic presbyopic corrections implanted with EDOF IOLs. Specifically, the aim of this study is to identify the minimum light intensity at which patients who underwent pseudophakic presbyopic correction with EDOF IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 45 to 75 years
排除标准
- •astigmatism >1.00 diopters
- •former incisional eye surgery
- •corneal or fundus disease
- •diabetes mellitus
- •autoimmune diseases
- •neurological or psychiatric diseases
- •posterior capsule rupture or lens misalignment
- •postoperative uncorrected distance visual acuity < 8/10.
研究组 & 干预措施
Study group
Patients who underwent uneventful pseudophakic presbyopic correction with yellow filter extended depth-of-focus (EDOF) IOLs (Vivity or Vivity toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)
干预措施: Phacoemulsification with EDOF IOLs (Procedure)
Control group
Patients of similar age who underwent uneventful cataract surgery implanted with yellow filter monofocal or monofocal toric IOLs (SN60WF or SN6ATx, Alcon Laboratories, Inc., Fort Worth, TX, USA)
结局指标
主要结局
Minimum Required Illuminance Level (MRIL)
时间窗: 6 months postoperatively
Minimum Required Illuminance Level (MRIL) (in lx) at which participants reach their optimal Uncorrected Distance Visual Acuity.
次要结局
未报告次要终点
研究者
Georgios Labiris
Associate Professor of Ophthalmology
Democritus University of Thrace