Clinical trial NCT04973384: Ocular Comorbidity in Atopic Dermatitis
Official title: Ocular Comorbidity in Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Keratoconjunctivitis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2021-07-22
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AD patients with current or previous ocular symptoms suspected to be atopic keratoconjunctivitis

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Danish talking
* Diagnosed with atopic dermatitis (AD)
* Current or previous ocular symptoms suspected to be atopic keratoconjunctivitis

Exclusion Criteria:

* No pause in eyedrops
* Ocular infections within the last 3 months
* Use of local or systemic antibiotics within the last 3 months
* Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, previous cerebral infarction or bleeding, lung diseases and autoimmune diseases other than atopic dermatitis and related comorbidities. The diseases are accepted if they are well treated or do not require treatment
* Current pregnant or breastfeeding
* Use of contact lenses, unless these are paused 2 weeks before the examination or they are due to keratoconus treatment
* If the eye symptoms turn out not to be related to atopic keratoconjunctivitis
* If it is assessed that the individual cannot participate sufficiently for the examination

Primary outcomes:
measure: Bulbar redness (BR) score
timeFrame: 1 day At examination
Secondary outcomes:
measure: Inferior Tear Meniscus Height (TMH)
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Non-invasive Keratograph Break-Up Time (NIKBUT)
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Meibo-Scan
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Ocular surface staining
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Osmolarity of the tears
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Fluorescein tear break up time (TFBUT)
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Schirmer's I test
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Intraocular pressure (IOP)
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Pentacam investigations for detection of keratoconus
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Tear cytokine analysis
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Tear proteomic analysis
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Tear MUC5AC analysis
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Goblet cell density
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Microbiome analysis
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Investigation of the infestation of Demodex
timeFrame: 1 day Cross-sectional at examination (one time)
measure: OSDI-score
timeFrame: 1 day Cross-sectional at examination (one time)
measure: PO-SCORAD
timeFrame: 1 day Cross-sectional at examination (one time)
measure: POEM
timeFrame: 1 day Cross-sectional at examination (one time)
measure: EASI
timeFrame: 1 day Cross-sectional at examination (one time)
measure: best-corrected logMAR acuity
timeFrame: 1 day Cross-sectional at examination (one time)
measure: Slit lamp examination
timeFrame: 1 day Cross-sectional at examination (one time)
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet-Glostrup
Study officials:
affiliation: Department of Ophthalmology, Rigshospitalet-Glostrup
name: Steffen Heegaard, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References: