Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, 2600, Denmark
NCT Number: NCT04973384
A clinical characterization of a large cohort of patients with different severities of AD and ocular symptoms/atopic keratoconjunktivitis (AKC). The data will contribute to assess the frequency of complications in order to give a rationale for focused prevention and treatment strategy.
This study is active but is not currently recruiting participants.
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Observational
Glostrup Municipality, 2600, Denmark
Atopic Dermatitis (AD), a very common inflammatory skin condition of child and adulthood, is strongly associated with ocular disease. Accordingly, about 20% experience conjunctivitis at some point, and many have chronic disease. Atopic keratoconjunctivitis (AKC) is the most feared as it may lead to blindness. Little is known about the etiology, the immune infiltrate, as well as predictive factors of AKC and the clinical characteristics of AD patients who develop this entity. We expect this project to enable clinicians to better identify AKC patients in the future as well as improve the understanding of the pathogenesis of AKC.
The ocular findings will be compared between AD severity and a control group without ocular symptoms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 day At examination
Difference in Bulbar redness (BR) score (Keratograph 5M, R-scan). Scale from 0-4. A higher score indicates more severe BR.
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Inferior Tear Meniscus Height (TMH) (Keratograph 5M)
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Non-invasive Keratograph Break-Up Time (NIKBUT) (Keratograph 5M)
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Meibo-Scan (Keratograph 5M). Scale from 0-3. A higher score indicates more morphological changes.
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Ocular surface staining
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Osmolarity of the tears (TearLab™)
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Fluorescein tear break up time (TFBUT)
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Schirmer's I test
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Intraocular pressure (IOP)
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the frequency of keratoconus
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the levels of inflammatory cytokines in the tears
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the protein profile in the tears
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the level of MUC5AC in tears
Time frame: 1 day Cross-sectional at examination (one time)
Difference in goblet cells density
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the amount of different species of the Microbiome of the ocular surface
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the amount of Demodex mites in the eyelashes/eyelids with non-invasive in vivo confocal microscopy
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the Ocular Surface Disease Index (OSDI) score. A 12-item questionnaire that gives a score on a scale from 0 to 100, where higher scores represent greater disability (mild [13-22 points], moderate [23-32 points], and severe [33-100 points]).
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the Patient-Oriented SCORing of Atopic Dermatitis (POSCORAD) score. A validated self-assessment tool to clinical evaluate AD severity, using subjective and objective criteria. A higher score indicates more severe AD.
Time frame: 1 day Cross-sectional at examination (one time)
Difference in the Patient Oriented Eczema Measure (POEM) score. A validated self-assessment tool to clinical evaluate AD severity. A scale from 0-28. A higher score indicates more severe AD.
Time frame: 1 day Cross-sectional at examination (one time)
Difference in Eczema Area and Severity Index (EASI) score. A tool used to measure the extent (area) and severity of atopic eczema. A scale from 0-72. A higher score indicates more severe AD.
Time frame: 1 day Cross-sectional at examination (one time)
Difference in best-corrected logMAR acuity
Time frame: 1 day Cross-sectional at examination (one time)
Difference in observations with slit lamp
Rigshospitalet, Denmark
Other
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