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临床试验/NCT03367793
NCT03367793已完成不适用

Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome

University of Houston2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月26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
30
试验地点
2
主要终点
Adapted Visual Acuity

研究概览

简要总结

This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.

详细描述

Individuals with Down syndrome suffer from significant ocular complications including high levels of lower-order refractive error (sphere and cylinder) and elevated levels of higher-order aberrations. These optical factors likely contribute to the poor acuity observed in this population. Current clinical prescribing practices may under-serve this community, as the cognitive demands of the subjective refraction sequence are difficult for this population and often leave clinicians to prescribe from objective clinical findings that target full correction of sphero-cylindrical refractive error. This prescribing practice can lead to sub-par outcomes given the fact that full lower-order corrections can exacerbate the effects of higher-order aberrations in more aberrated eyes.

For this study, individuals with Down syndrome will be dispensed three pairs of spectacles for 2 months each, in random order: one clinically-derived, and two objectively-derived refractions based upon methods designed to optimize a given metric of retinal image quality which takes into consideration the wavefront aberration measurements of the eye. Both initial and adapted visual acuity in the presence of each correction will be evaluated to determine whether the objectively-derived refractions outperform clinically-derived refractions.

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, Investigator)

入排标准

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

入选标准

  • Diagnosis of Down syndrome

排除标准

  • Nystagmus (Involuntary beating movement of the eyes)
  • Visually significant media opacities (e.g. cataracts or corneal scars)
  • Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)
  • Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)

结局指标

主要结局

Adapted Visual Acuity

时间窗: two months

Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.

次要结局

  • Spectacle Assessment Survey Question 2(two months)
  • Spectacle Assessment Survey Question 1(two months)
  • Initial Visual Acuity(1 day)
  • Spectacle Wear Time(two months)
  • Spectacle Assessment Survey Question 3(two months)

研究者

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

Heather A. Anderson

Associate Professor

University of Houston

研究点 (2)

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