Clinical trial NCT04501172: Impact of Spectacles on Compliance to Mask-wearing Directives
Official title: Impact of Spectacles on Compliance to Mask-wearing Directives in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: face masks
spectacles
contact lenses
compliance in mask-wearing directive
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 1214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Poor knowledge of Greek language

Primary outcomes:
measure: Demographic characteristics
timeFrame: last 3 months
measure: Compliance to mask-wearing directives
timeFrame: last 3 months
measure: Questionnaire subscale: Near vision
timeFrame: last 3 months
measure: Questionnaire subscale: Distance vision
timeFrame: last 3 months
measure: Questionnaire subscale: Ocular discomfort
timeFrame: last 3 months
measure: Questionnaire subscale: Driving
timeFrame: last 3 months
measure: Questionnaire subscale: Limitation
timeFrame: last 3 months
measure: Questionnaire subscale: Collaboration
timeFrame: last 3 months
measure: Questionnaire subscale: Need for help
timeFrame: last 3 months
measure: Questionnaire subscale: Emotional impact
timeFrame: last 3 months
Secondary outcomes:
measure: Assessment of the relationship between the compliance to mask-wearing directives and the use of spectacles
timeFrame: immediately after the completion of data collection
measure: Assessment of the relationship between the compliance to mask-wearing directives and the other demographic characteristics
timeFrame: immediately after the completion of data collection
measure: Assessment of the relationship between the compliance to mask-wearing directives and the questionnaire items
timeFrame: immediately after the completion of data collection
measure: Assessment of the relationship between demographic characteristics and the 20 questionnaire items
timeFrame: immediately after the completion of data collection
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Department of Ophthalmolgy, University Hospital of Alexandroupolis, Greece
name: Labiris Georgios, MD, PhD
role: STUDY_CHAIR
References: