跳至主要内容
临床试验/NCT03456245
NCT03456245已完成不适用

A Validation Study of Mobile Technologies for Assessing Visual Acuity and Eye Health Among Older Adults in India

Harvard School of Public Health (HSPH)0 个研究点目标入组 205 人开始时间: 2016年8月15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
205
主要终点
Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters)

研究概览

简要总结

Study compares four portable vision measurement and eye-imaging technologies in terms of accuracy and time and ease of use with older adult (ages 40-100) participants in a developing-country setting (India). Specifically, the five portable devices will be measured against the baseline of the traditional eye-examination techniques, including the use of eye charts and phoropters.

详细描述

Non-communicable diseases (NCDs) are a large and increasingly costly problem for India. Recent research estimates that NCDs could cost the Indian economy US$6.2 trillion from 2012-2030 if left unaddressed. For some NCDs, new solutions will need to be developed for diagnosis and treatment, while, for others, the necessary interventions exist but are not readily available to all who need them. Visual impairment is one area of health in which limited access to diagnostic and treatment technologies jeopardizes the health and economic well-being of the population. This is particularly true in India, where the population is rapidly aging and, despite the presence of some high-quality medical facilities, there remains a large burden of unaddressed visual impairment.

Loss of visual acuity can negatively impact individual and household income by reducing productivity or hours worked among the visually impaired; it can also affect economic wellbeing via the need for caretakers. There are two key tests that determine visual acuity and measure vision loss:

  1. Basic visual acuity (BVA), which is assessed using the naked eye or, when applicable, eyeglasses, and
  2. Best-corrected visual acuity (BCVA), which uses refraction to determine eyeglass/contact lens prescription.

In addition, diagnosing vision-hindering eye conditions requires specific medications or surgical procedures. Diagnosis of glaucoma, cataracts, or diabetic retinopathy typically requires a physician to examine a patient's retinas, corneas, and/or pupils at close range using specialized equipment, in conjunction with the visual acuity tests described above.

BCVA tests typically require heavy, cumbersome, and expensive equipment such as phoropters (instruments that measure the refractive state of the eye). Likewise, eye diseases typically require the use of specialized equipment such as slit lamp microscopes, ophthalmoscopes, and tonometers.

研究设计

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

入排标准

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

入选标准

  • Individuals aged 40-100 coming to Sankara Eye Hospital from surrounding urban/rural communities.

排除标准

  • Individuals under the age of
  • Blind individuals
  • Individuals with acute glaucoma, eye trauma/injury, infections such as conjunctivitis
  • Individuals physically/cognitively incapable of following basic instructions and sitting/standing still in order to use devices.

结局指标

主要结局

Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters)

时间窗: 1-2 hours

Measurements of participants' best visual acuity as measured by mobile devices compared to "gold standard" of subjective refraction

次要结局

未报告次要终点

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Bloom

Professor

Harvard School of Public Health (HSPH)

相似试验