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临床试验/NCT02279446
NCT02279446
Unknown
不适用

Development of a Validated Chart for Intermediate Vision Assessment

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 400 人2014年10月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Myopia
发起方
Democritus University of Thrace
入组人数
400
试验地点
1
主要终点
Intermediate Visual Acuity (IVA)
最后更新
11年前

概览

简要总结

Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.

详细描述

Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity (IVA). It is known that no validated method for the evaluation of IVA exists. Primary objective of the study is to validate a specific computer-based chart (optotype) that will enable: a) comparative studies among different groups of presbyopic patients with refractive errors (ie. myopia, hyperopia, and/or astigmatism), and, b) assessment of the efficacy of surgical refractive procedures (ie. LASIK) on presbyopic patients. Intermediate Visual acuity chart is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5 Validation of the computer-based IVA chart will be done by correlating the results of the IVA chart to the corresponding ones from the validated 20/20 distant and Jaeger near visual acuity charts, in a random sample of study participants with different refractive errors and different near and distant visual acuities.

注册库
clinicaltrials.gov
开始日期
2014年10月
结束日期
2015年4月
最后更新
11年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Georgios Labiris

Assistant Professor

Democritus University of Thrace

入排标准

入选标准

  • native Greek participants or foreigners with perfect knowledge (verbal and written) of Greek language

排除标准

  • glaucoma or suspicion for glaucoma,
  • corneal disease or suspicion for corneal disease
  • fundus disease or suspicion for fundus disease
  • pregnancy or nursing,
  • underlying autoimmune disease
  • mental or neurologic disease

结局指标

主要结局

Intermediate Visual Acuity (IVA)

时间窗: 6 months

Number of participants that their intermediate visual acuity measured with the "intermediate visual acuity chart" will be statistically correlated with distant visual acuity (measured by 20/20 chart) and near visual acuity (measured by Jaeger chart)

研究点 (1)

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