Ocular Comorbidity in Atopic Dermatitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Bulbar redness (BR) score [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.
Secondary Outcome Measures
- Inferior Tear Meniscus Height (TMH) [1 day Cross-sectional at examination (one time)]
Difference in Inferior Tear Meniscus Height (TMH) (Keratograph 5M)
- Non-invasive Keratograph Break-Up Time (NIKBUT) [1 day Cross-sectional at examination (one time)]
Difference in Non-invasive Keratograph Break-Up Time (NIKBUT) (Keratograph 5M)
- Meibo-Scan [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.
- Ocular surface staining [1 day Cross-sectional at examination (one time)]
Difference in Ocular surface staining
- Osmolarity of the tears [1 day Cross-sectional at examination (one time)]
Difference in Osmolarity of the tears (TearLab™)
- Fluorescein tear break up time (TFBUT) [1 day Cross-sectional at examination (one time)]
Difference in Fluorescein tear break up time (TFBUT)
- Schirmer's I test [1 day Cross-sectional at examination (one time)]
Difference in Schirmer's I test
- Intraocular pressure (IOP) [1 day Cross-sectional at examination (one time)]
Difference in Intraocular pressure (IOP)
- Pentacam investigations for detection of keratoconus [1 day Cross-sectional at examination (one time)]
Difference in the frequency of keratoconus
- Tear cytokine analysis [1 day Cross-sectional at examination (one time)]
Difference in the levels of inflammatory cytokines in the tears
- Tear proteomic analysis [1 day Cross-sectional at examination (one time)]
Difference in the protein profile in the tears
- Tear MUC5AC analysis [1 day Cross-sectional at examination (one time)]
Difference in the level of MUC5AC in tears
- Goblet cell density [1 day Cross-sectional at examination (one time)]
Difference in goblet cells density
- Microbiome analysis [1 day Cross-sectional at examination (one time)]
Difference in the amount of different species of the Microbiome of the ocular surface
- Investigation of the infestation of Demodex [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
- OSDI-score [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]).
- PO-SCORAD [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.
- POEM [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.
- EASI [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.
- best-corrected logMAR acuity [1 day Cross-sectional at examination (one time)]
Difference in best-corrected logMAR acuity
- Slit lamp examination [1 day Cross-sectional at examination (one time)]
Difference in observations with slit lamp
Eligibility Criteria
Criteria
Inclusion Criteria:
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Danish talking
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Diagnosed with atopic dermatitis (AD)
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Current or previous ocular symptoms suspected to be atopic keratoconjunctivitis
Exclusion Criteria:
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No pause in eyedrops
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Ocular infections within the last 3 months
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Use of local or systemic antibiotics within the last 3 months
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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
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Current pregnant or breastfeeding
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Use of contact lenses, unless these are paused 2 weeks before the examination or they are due to keratoconus treatment
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If the eye symptoms turn out not to be related to atopic keratoconjunctivitis
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If it is assessed that the individual cannot participate sufficiently for the examination
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Ophthalmology, Rigshospitalet-Glostrup | Glostrup | Denmark | 2600 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- Oslo University Hospital
Investigators
- Principal Investigator: Steffen Heegaard, MD, DMSci, Department of Ophthalmology, Rigshospitalet-Glostrup
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-20069664