Impact of Spectacles on Compliance to Mask-wearing Directives

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501172
• Other study ID #: ES8/Th5/25-06-2020
• Status: Completed
• Start date: June 25, 2020
• Est. completion date: August 14, 2020

Study information

• Verified date: September 2020
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: August 14, 2020
• Est. primary completion date: July 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age >18 years old

• Adequate literacy of Greek language

• Permanent residence in Greece

Exclusion Criteria:

• Poor knowledge of Greek language

Related Conditions & MeSH terms

• Covid19

Intervention

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.

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Compliance to mask-wearing directives	Compliance to mask-wearing directives; Yes, always; Yes, almost always; Sometimes; No, almost never; No, never	last 3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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