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临床试验/NCT05028790
NCT05028790已完成不适用

Evaluating Contact Lens Optics

David A Berntsen, OD PhD2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年2月27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
16
试验地点
2
主要终点
Visual Performance

研究概览

简要总结

This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants were masked to the order in which they wore contact lenses

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Able to read and understand the informed consent document
  • 18 to 39 years of age (inclusive)
  • Best corrected visual acuity of 20/25 or better in the right eye
  • Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

排除标准

  • Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
  • History of ocular trauma or surgery causing abnormal or distorted vision
  • Current Rigid Gas Permeable (RGP) contact lens wearers
  • Unwilling to have contact lens fit photographed
  • Pregnant and/or lactating females, by self-report

结局指标

主要结局

Visual Performance

时间窗: Through completion of study visit, an average of 2.5 hours

Low contrast visual acuity was measured for each participant while wearing each of the two lenses

次要结局

  • Spherical Equivalent Refractive Error On-axis(Through completion of study visit, an average of 2.5 hours)
  • Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina(Through completion of study visit, an average of 2.5 hours)
  • Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina(Through completion of study visit, an average of 2.5 hours)
  • Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina(Through completion of study visit, an average of 2.5 hours)
  • Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina(Through completion of study visit, an average of 2.5 hours)

研究者

发起方
David A Berntsen, OD PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David A Berntsen, OD PhD

Associate Professor

University of Houston

研究点 (2)

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