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临床试验/NCT06335212
NCT06335212已完成不适用

Peripheral Defocus Profile of Multifocal Minus Contact Lenses

State University of New York College of Optometry1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年6月1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
19
试验地点
1
主要终点
refractive power

研究概览

简要总结

Purpose: Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. As such, multifocal soft contact lenses (MFCLs) have been utilized for myopia control in school-aged children, with variable efficacies. One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression. Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (SVCLs) and MFCLs of different Add powers.

Methods: Subjects with -1.00 D to -10.00 D of myopia (SE, determined with manifest refraction) were custom fit with both single vision (SV) and MFCLs (+2.00 and +4.00 D Add; provided by Specialeyes) in both eyes. These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 8.0mm. Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia. Data in the right eye was used for analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-30 years of age
  • spherical equivalent (determined with subjective refraction) between -1.00 and -10.00 D in each eye, spherical power between -0.75 and -10.00 D and cylindrical power ≤ 1.50 D
  • monocular best corrected visual acuity 20/25 or better
  • no previous contact lens experience required
  • no history of ocular pathology, binocular vision anomalies, or refractive surgery.

排除标准

  • 未提供

结局指标

主要结局

refractive power

时间窗: Relative pupil limited optical power profile was measured once within one month from their first visit when the subjects were uncorrected or wearing contact lenses of various designs

Relative pupil limited optical power profile

次要结局

未报告次要终点

研究者

发起方
State University of New York College of Optometry
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaoying Zhu, OD, PhD, MD, MS, FAAO

Assistant Clinical Professor

State University of New York College of Optometry

研究点 (1)

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