H16.2
Conditions
Interventions
Group 1: Each healthy subject goes through the measurements a total of three times
once with mouth-nose protection, once with FFP2 mask and once completely without mask. The order is randomized to avoid distortion of the measurement results by the measurement repetitions.
Group 2:
once with mouth-nose protection, once with FFP2 mask and once completely without mask. The order is randomized to avoid distortion of the measurement results by the measurement repetitions.
Sponsors
Augenklinik Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Healthy: - age = 18 Years - Ability to give consent - signed declaration of consent - Male and female test persons without an ophthalmologically diagnosed dry eye including all subcategories of the hyposecretory and hyperevaporative form as well as autoimmune forms - McMonnies Questionnaire =14,5 - Contact lenses have to be removed at least 30 minutes before the examination Dry eye: - age = 18 Years - Ability to give consent - signed declaration of consent - Male and female test persons with an ophthalmologically diagnosed dry eye including all subcategories of the hyposecretory and hyperevaporative form as well as autoimmune forms - McMonnies Questionnaire =14,5 - Contact lenses have to be removed at least 30 minutes before the examination
Exclusion criteria
Exclusion criteria: Healthy subjects: - Age: 14.5 Dry-eye patients: - Age: <18 years - epilepsy - lack of consent - Inability to give consent or withdrawal of the signed consent - Inserted contact lenses unless they have been removed at least 30 minutes before the examination - McMonnie's Questionnaire =14.5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each group (healthy and dry eye) contains 42 people. The number is based on the main variable NIKBUT (Noninvasive-Keratograph-measured-break-up-time). A difference of =2 seconds is considered as statistically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| With LipiView: Lipid layer thickness With Keratograph: Tear meniscus high, Tear film performance, Lipid layer, redness of bulbus | — |
Countries
Germany
Contacts
Public ContactEva-Maria Zimzik
Universitätsklinikum Düsseldorf
Outcome results
None listed