Impact of Spectacles on Compliance to Mask-wearing Directives

NCT04501172 | Completed DMC

• 1 other identifier: ES8/Th5/25-06-2020
• Study Type: observational
• Target: 1,214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

face masks; spectacles; contact lenses; compliance in mask-wearing directive

Outcome Measures

Primary Outcomes (10)

• Demographic characteristics

  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)

  last 3 months

• Compliance to mask-wearing directives

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

  last 3 months

• Questionnaire subscale: Near vision

  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

  last 3 months

• Questionnaire subscale: Distance vision

  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

  last 3 months

• Questionnaire subscale: Ocular discomfort

  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)

  last 3 months

• Questionnaire subscale: Driving

  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

  last 3 months

• Questionnaire subscale: Limitation

  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)

  last 3 months

• Questionnaire subscale: Collaboration

  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

  last 3 months

• Questionnaire subscale: Need for help

  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)

  last 3 months

• Questionnaire subscale: Emotional impact

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

  last 3 months

Secondary Outcomes (4)

• 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

Study Arms (1)

Study group

People who use social networks, with permanent residence in Greece, aged above 18 years old and adequate literacy of Greek language

Behavioral: Questionnaire completion

Interventions

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: 1. participant's demographic characteristics with questions regarding age, visual acuity - refractive error, spectacles and contact lenses use, and compliance to mask-wearing directives. 2. 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.

Study group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who use social networks, with permanent residence in Greece, aged above 18 years old and adequate literacy of Greek language

You may qualify if:

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

You may not qualify if:

• Poor knowledge of Greek language

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Labiris Georgios, MD, PhD

  Department of Ophthalmolgy, University Hospital of Alexandroupolis, Greece

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 6, 2020
• Study Start: June 25, 2020
• Primary Completion: July 24, 2020
• Study Completion: August 14, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

GR (1)