Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome
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
- 否
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
Heather A. Anderson
Associate Professor
University of Houston
