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临床试验/NCT05059041
NCT05059041已完成2 期

Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome

Ohio State University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年5月6日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
42
试验地点
2
主要终点
Distance Visual Acuity

研究概览

简要总结

Individuals with Down syndrome (DS) live with visual deficits due, in part, to elevated levels of higher-order optical aberrations (HOA). HOAs are distortions/abnormalities in the structure of the refractive components of the eye (i.e. the cornea and the lens) that, if present, can result in poor quality focus on the retina, thus negatively impacting vision. HOAs in the general population are overall low, and thus not ordinarily considered during the eye examination and determination of refractive correction. However, for some populations, such as individuals with DS, HOAs are elevated, and thus the commonly used clinical techniques to determine refractive corrections may fall short. The most common clinical technique for refractive correction determination is subjective refraction whereby a clinician asks the patient to compare different lens options and select the lens that provides the best visual outcome. Given the cognitive demands of the standard subjective refraction technique, clinicians rely on objective clinical techniques to prescribe optical corrections for individuals with DS. This is problematic, because it may result in errors for eyes with elevated HOA given that these techniques do not include measurement of the HOAs. The proposed research evaluates the use of objective wavefront measurements that quantify the HOAs of the eye as a basis for refractive correction determination for patients with DS. The specific aim is to determine whether dilation of the eyes is needed prior to objective wavefront measurements. Dilation of the eyes increases the ability to measure the optical quality of the eye and paralyzes accommodation (the natural focusing mechanism of the eye), which could be beneficial in determining refractions. However, the use of dilation lengthens the process for determining prescriptions and may be less desirable for patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Down syndrome
  • Able to be dilated
  • Able to fixate for study measures
  • Able to respond for visual acuity testing

排除标准

  • Ocular nystagmus
  • History of ocular or refractive surgery (strabismus surgery is okay)
  • Corneal or lenticular opacities
  • Ocular disease

研究组 & 干预措施

Dilated first, non-dilated second

Experimental

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained after dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained before dilation.

干预措施: Dilated Refraction (Device)

Dilated first, non-dilated second

Experimental

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained after dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained before dilation.

干预措施: Non-Dilated Refraction (Device)

Non-dilated first, dilated second

Experimental

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained before dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained after dilation.

干预措施: Dilated Refraction (Device)

Non-dilated first, dilated second

Experimental

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained before dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained after dilation.

干预措施: Non-Dilated Refraction (Device)

结局指标

主要结局

Distance Visual Acuity

时间窗: 1 day

Distance (in LogMAR) visual acuity will be measured in the right eye with the British Standard Letter set or HOTV Matching for participants unable to name letters. Measurements will be obtained while the participant wears spectacle lenses based on their pre- and post-dilation refractions, respectively (from Visit 1). The order of testing is randomized. The primary outcome is the difference in distance visual acuity measurements calculated as visual acuity when wearing pre-dilation lens minus wearing post-dilation lens.

次要结局

  • Near Visual Acuity(1 day)
  • Participant Rating of Distance Vision Quality(1 day)
  • Participant Rating of Vision Quality at Near(1 day)
  • Participant Overall Preference for Prescriptions(1 day)

研究者

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

Heather Anderson OD, PhD

Associate Professor

Ohio State University

研究点 (2)

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