Impact of Spectacles on Compliance to Mask-wearing Directives

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Behavioral: Questionnaire completion

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1214

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • University Hospital of Alexandroupolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Poor knowledge of Greek language

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics	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)	last 3 months
Compliance to mask-wearing directives	Compliance to mask-wearing directives; Yes, always; Yes, almost always; Sometimes; No, almost never; 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; 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	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; 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	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; 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	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; 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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the relationship between the compliance to mask-wearing directives and the use of spectacles	Chi-squared test will be performed to assess if the compliance to mask-wearing directives is related to 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	Chi-squared test will be performed to assess if the compliance to mask-wearing directives is related to 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	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)	immediately after the completion of data collection
Assessment of the relationship between demographic characteristics and the 20 questionnaire items	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)	immediately after the completion of data collection

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Study Chair: Labiris Georgios, MD, PhD, Department of Ophthalmolgy, University Hospital of Alexandroupolis, Greece

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): July 24, 2020
• Study Completion (Actual): August 14, 2020

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: August 1, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: contact lenses; spectacles; face masks; compliance in mask-wearing directive
• Other Study ID Numbers: ES8/Th5/25-06-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No