An observational study in Atopic Keratoconjunctivitis, sponsored by Rigshospitalet, Denmark. Active, not recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
27 studies on the registry are indexed under Keratoconjunctivitis; 3 are open to participants now.
Browse Keratoconjunctivitis studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
AD patients with current or previous ocular symptoms suspected to be atopic keratoconjunctivitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bulbar redness (BR) score
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 At examination
Inferior Tear Meniscus Height (TMH)
Difference in Inferior Tear Meniscus Height (TMH) (Keratograph 5M)
Time frame: 1 day Cross-sectional at examination (one time)
Non-invasive Keratograph Break-Up Time (NIKBUT)
Difference in Non-invasive Keratograph Break-Up Time (NIKBUT) (Keratograph 5M)
Time frame: 1 day Cross-sectional at examination (one time)
Meibo-Scan
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)
Ocular surface staining
Difference in Ocular surface staining
Time frame: 1 day Cross-sectional at examination (one time)
Osmolarity of the tears
Difference in Osmolarity of the tears (TearLab™)
Time frame: 1 day Cross-sectional at examination (one time)
Fluorescein tear break up time (TFBUT)
Difference in Fluorescein tear break up time (TFBUT)
Time frame: 1 day Cross-sectional at examination (one time)
Schirmer's I test
Difference in Schirmer's I test
Time frame: 1 day Cross-sectional at examination (one time)
Intraocular pressure (IOP)
Difference in Intraocular pressure (IOP)
Time frame: 1 day Cross-sectional at examination (one time)
Pentacam investigations for detection of keratoconus
Difference in the frequency of keratoconus
Time frame: 1 day Cross-sectional at examination (one time)
Tear cytokine analysis
Difference in the levels of inflammatory cytokines in the tears
Time frame: 1 day Cross-sectional at examination (one time)
Tear proteomic analysis
Difference in the protein profile in the tears
Time frame: 1 day Cross-sectional at examination (one time)
Tear MUC5AC analysis
Difference in the level of MUC5AC in tears
Time frame: 1 day Cross-sectional at examination (one time)
Goblet cell density
Difference in goblet cells density
Time frame: 1 day Cross-sectional at examination (one time)
Microbiome analysis
Difference in the amount of different species of the Microbiome of the ocular surface
Time frame: 1 day Cross-sectional at examination (one time)
Investigation of the infestation of Demodex
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)
OSDI-score
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)
PO-SCORAD
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)
POEM
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)
EASI
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)
best-corrected logMAR acuity
Difference in best-corrected logMAR acuity
Time frame: 1 day Cross-sectional at examination (one time)
Slit lamp examination
Difference in observations with slit lamp
Time frame: 1 day Cross-sectional at examination (one time)
Plan to share: No
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Ran from Aug 2021 to primary completion in Feb 2024, 30 months.
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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