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临床试验/NCT04501172
NCT04501172已完成不适用

Impact of Spectacles on Compliance to Mask-wearing Directives in Greece

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 1,214 人开始时间: 2020年6月25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
1,214
试验地点
1
主要终点
Demographic characteristics

研究概览

简要总结

Primary objective of this study is to identify the compliance of Greek people in mask-wearing directive and explore potential associations with refractive errors, spectacles and contact lenses use.

详细描述

Present study aims to identify whether Greek people have complied with mask-wearing directive and to investigate the correlation of outcomes with visual acuity - refractive errors, spectacles and contact lenses use. For the purposes of this research, a questionnaire of 20 items including the following sub scales have been developed: a) near vision, b) distance vision, c) ocular discomfort, d) driving, e) limitations, need for help, work collaboration, and emotional impact

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old
  • Adequate literacy of Greek language
  • Permanent residence in Greece

排除标准

  • Poor knowledge of Greek language

结局指标

主要结局

Demographic characteristics

时间窗: last 3 months

1. Gender 2. Age 3. Use of spectacles (a. no use, b. for distance, c. for near, d. for distance and near) 4. Use of contact lenses (a. no use, b. rarely, c. frequently, d. almost always) 5. Belonging to a vulnerable group (1. No, 2. Yes, 3. I don't know) 6. Binocular Distance Best Spectacle-Corrected Visual Acuity (if it is known) (1. I don't know, 2. \<1/10, 3. 1-3/10, 4. 4-6/10, 5. 7-8/10, 6. 9-10/10)

Compliance to mask-wearing directives

时间窗: last 3 months

Compliance to mask-wearing directives 1. Yes, always 2. Yes, almost always 3. Sometimes 4. No, almost never 5. No, never

Questionnaire subscale: Near vision

时间窗: last 3 months

Difficulty in near vision activities (reading a printed document in the workplace or in daily life, reading a document on computer in the workplace or in daily life, reading a message on mobile phone) when using a face mask 1. No difficulty 2. Little difficulty 3. Some difficulty 4. Great difficulty 5. I have stopped this activity because of my vision and the use of face mask 6. I need to remove my face mask

Questionnaire subscale: Distance vision

时间窗: last 3 months

Difficulty in distance vision activities (recognizing people on the opposite sidewalk, reading road and shop signs, crossing roads) when using a face mask 1. No difficulty 2. Little difficulty 3. Some difficulty 4. Great difficulty 5. I have stopped this activity because of my vision and the use of face mask 6. I need to remove my face mask

Questionnaire subscale: Ocular discomfort

时间窗: last 3 months

Ocular discomfort (tearing sensation, stinging sensation, general discomfort) when using a face mask 5-point Likert scale (1 = I absolutely agree / 5 = I absolutely disagree)

Questionnaire subscale: Driving

时间窗: last 3 months

Difficulty in driving (during day or night, in known or unknown places) when using a face mask 1. No difficulty 2. Little difficulty 3. Some difficulty 4. Great difficulty 5. I have stopped this activity because of my vision and the use of face mask 6. I need to remove my face mask

Questionnaire subscale: Limitation

时间窗: last 3 months

Limitation during physical activity, entertainment, social relationships, professional and learning development when using a face mask 5-point Likert scale (1 = I absolutely agree / 5 = I absolutely disagree)

Questionnaire subscale: Collaboration

时间窗: last 3 months

Difficulty in collaboration with colleagues in the workplace when using a face mask 1. No difficulty 2. Little difficulty 3. Some difficulty 4. Great difficulty 5. I have stopped this activity because of my vision and the use of face mask 6. I need to remove my face mask

Questionnaire subscale: Need for help

时间窗: last 3 months

Need for help during shopping (supermarket, grocery store, bakery) or in public services (bank etc) when using a face mask 5-point Likert scale (1 = I absolutely agree / 5 = I absolutely disagree)

Questionnaire subscale: Emotional impact

时间窗: last 3 months

Emotional charge when using a face mask 5-point Likert scale (1 = I absolutely agree / 5 = I absolutely disagree)

次要结局

  • Assessment of the relationship between the compliance to mask-wearing directives and the use of spectacles(immediately after the completion of data collection)
  • Assessment of the relationship between the compliance to mask-wearing directives and the other demographic characteristics(immediately after the completion of data collection)
  • Assessment of the relationship between the compliance to mask-wearing directives and the questionnaire items(immediately after the completion of data collection)
  • Assessment of the relationship between demographic characteristics and the 20 questionnaire items(immediately after the completion of data collection)

研究者

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

Georgios Labiris

Associate Professor of Ophthalmology

Democritus University of Thrace

研究点 (1)

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