Impact of Spectacles on Compliance to Mask-wearing Directives

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 85 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Covid19

Being tested

Questionnaire completion

Keywords

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

Medical subject headings

COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Questionnaire completionBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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)

   Measured: last 3 months

2. 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

   Measured: last 3 months

3. 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

   Measured: last 3 months

4. 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

   Measured: last 3 months

5. 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)

   Measured: last 3 months

6. 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

   Measured: last 3 months

7. 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)

   Measured: last 3 months

8. 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

   Measured: last 3 months

9. 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)

   Measured: last 3 months

10. Questionnaire subscale: Emotional impact

    Emotional charge when using a face mask

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

    Measured: last 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Aug 2020
2. Study start25 Jun 2020
3. Primary completion24 Jul 2020
4. Study completion14 Aug 2020

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Covid19Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.