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Completed

NCT Number: NCT04501172

Impact of Spectacles on Compliance to Mask-wearing Directives

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Poor knowledge of Greek language

Treatment and study plan

Questionnaire completion

Behavioral

Participants are contacted through social networks (Facebook) which provide a link to website that contains the questionnaire. Then, they complete the questionnaire which consists of the following 2 parts:

  • participant's demographic characteristics with questions regarding age, visual acuity - refractive error, spectacles and contact lenses use, and compliance to mask-wearing directives.
  • 20 items that construct 5 subscales: a) near vision (5 items), b) distance vision (3 items), c) ocular discomfort (3 items), d) driving (2 items), e) limitations (3 items), need for help (2 items), work collaboration (1 item), and emotional impact (1 item).

The impact of spectacles on the compliance of Greek people to mask-wearing directives will be assessed via this questionnaire.

Primary outcomes

  1. Demographic characteristics

    Time frame: last 3 months

    • Gender
    • Age
    • Use of spectacles (a. no use, b. for distance, c. for near, d. for distance and near)
    • Use of contact lenses (a. no use, b. rarely, c. frequently, d. almost always)
    • Belonging to a vulnerable group (1. No, 2. Yes, 3. I don't know)
    • 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)

  2. Compliance to mask-wearing directives

    Time frame: last 3 months

    Compliance to mask-wearing directives

    • Yes, always
    • Yes, almost always
    • Sometimes
    • No, almost never
    • No, never

  3. Questionnaire subscale: Near vision

    Time frame: 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

    • No difficulty
    • Little difficulty
    • Some difficulty
    • Great difficulty
    • I have stopped this activity because of my vision and the use of face mask
    • I need to remove my face mask

  4. Questionnaire subscale: Distance vision

    Time frame: 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

    • No difficulty
    • Little difficulty
    • Some difficulty
    • Great difficulty
    • I have stopped this activity because of my vision and the use of face mask
    • I need to remove my face mask

  5. Questionnaire subscale: Ocular discomfort

    Time frame: 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)

  6. Questionnaire subscale: Driving

    Time frame: last 3 months

    Difficulty in driving (during day or night, in known or unknown places) when using a face mask

    • No difficulty
    • Little difficulty
    • Some difficulty
    • Great difficulty
    • I have stopped this activity because of my vision and the use of face mask
    • I need to remove my face mask

  7. Questionnaire subscale: Limitation

    Time frame: 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)

  8. Questionnaire subscale: Collaboration

    Time frame: last 3 months

    Difficulty in collaboration with colleagues in the workplace when using a face mask

    • No difficulty
    • Little difficulty
    • Some difficulty
    • Great difficulty
    • I have stopped this activity because of my vision and the use of face mask
    • I need to remove my face mask

  9. Questionnaire subscale: Need for help

    Time frame: 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)

  10. Questionnaire subscale: Emotional impact

    Time frame: last 3 months

    Emotional charge when using a face mask

    5-point Likert scale (1 = I absolutely agree / 5 = I absolutely disagree)

Secondary outcomes

  1. Assessment of the relationship between the compliance to mask-wearing directives and the use of spectacles

    Time frame: immediately after the completion of data collection

    Chi-squared test will be performed to assess if the compliance to mask-wearing directives is related to the use of spectacles

  2. Assessment of the relationship between the compliance to mask-wearing directives and the other demographic characteristics

    Time frame: immediately after the completion of data collection

    Chi-squared test will be performed to assess if the compliance to mask-wearing directives is related to the other demographic characteristics

  3. Assessment of the relationship between the compliance to mask-wearing directives and the questionnaire items

    Time frame: immediately after the completion of data collection

    Chi-squared test will be performed to assess if the compliance to mask-wearing directives is related to the 20 questionnaire items and the corresponding subscales (outcome measures 3-10)

  4. Assessment of the relationship between demographic characteristics and the 20 questionnaire items

    Time frame: immediately after the completion of data collection

    Chi-squared test will be performed to assess if demographic characteristics are related to the 20 items of the questionnaire and to the corresponding subscales (outcome measures 3-10)

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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