Ocular Comorbidity in Atopic Dermatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Keratoconjunctivitis

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Pernille Rævdal, MD; Phone Number: +4520804435; Email: pernille.raevdal.01@regionh.dk
• Study Contact Backup: Name: Steffen Heegaard, MD, DMSci; Email: steffen.heegaard@regionh.dk

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Recruiting
    • Department of Ophthalmology, Rigshospitalet-Glostrup
    • Contact: Steffen Heegaard, MD, DMSci; Email: steffen.heegaard@regionh.dk
    • Contact: Pernille Rævdal, MD; Phone Number: 20804435; Email: raevdal.pernille@gmail.com
    • Principal Investigator: Steffen Heegaard, MD, DMSci
    • Sub-Investigator: Pernille Rævdal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

AD patients with current or previous ocular symptoms suspected to be atopic keratoconjunctivitis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day At examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inferior Tear Meniscus Height (TMH)	Difference in Inferior Tear Meniscus Height (TMH) (Keratograph 5M)	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)	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.	1 day Cross-sectional at examination (one time)
Ocular surface staining	Difference in Ocular surface staining	1 day Cross-sectional at examination (one time)
Osmolarity of the tears	Difference in Osmolarity of the tears (TearLab™)	1 day Cross-sectional at examination (one time)
Fluorescein tear break up time (TFBUT)	Difference in Fluorescein tear break up time (TFBUT)	1 day Cross-sectional at examination (one time)
Schirmer's I test	Difference in Schirmer's I test	1 day Cross-sectional at examination (one time)
Intraocular pressure (IOP)	Difference in Intraocular pressure (IOP)	1 day Cross-sectional at examination (one time)
Pentacam investigations for detection of keratoconus	Difference in the frequency of keratoconus	1 day Cross-sectional at examination (one time)
Tear cytokine analysis	Difference in the levels of inflammatory cytokines in the tears	1 day Cross-sectional at examination (one time)
Tear proteomic analysis	Difference in the protein profile in the tears	1 day Cross-sectional at examination (one time)
Tear MUC5AC analysis	Difference in the level of MUC5AC in tears	1 day Cross-sectional at examination (one time)
Goblet cell density	Difference in goblet cells density	1 day Cross-sectional at examination (one time)
Microbiome analysis	Difference in the amount of different species of the Microbiome of the ocular surface	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	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]).	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.	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.	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.	1 day Cross-sectional at examination (one time)
best-corrected logMAR acuity	Difference in best-corrected logMAR acuity	1 day Cross-sectional at examination (one time)
Slit lamp examination	Difference in observations with slit lamp	1 day Cross-sectional at examination (one time)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: Steffen Heegaard, MD, DMSci, Department of Ophthalmology, Rigshospitalet-Glostrup

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Keratoconjunctivitis
• Other Study ID Numbers: H-20069664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No