Cross-Sectional Study for an Ocular Imaging-Based Predictive Model of Inflammatory Skin Diseases Grounded in Traditional Chinese Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire collection.
- Who it may be relevant to
- Registry conditions: Psoriasis, Atopic Dermatitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study is a cross-sectional, observational investigation designed to develop and validate a noninvasive ocular imaging-based predictive model for major inflammatory skin diseases, including psoriasis, atopic dermatitis, and urticaria. Grounded in Traditional Chinese Medicine (TCM) ocular diagnostic theory and integrated with advanced computer vision techniques, the study aims to establish objective, quantifiable biomarkers derived from scleral and bulbar conjunctival images. Approximately 950 participants (patients with psoriasis, atopic dermatitis, urticaria, and healthy controls) will be recruited from a tertiary academic hospital. Standardized high-resolution ocular images will be collected alongside comprehensive clinical, demographic, and comorbidity data. Disease severity will be assessed using validated clinical scoring systems (e.g., PASI, EASI, UAS7, DLQI). Image analysis will combine traditional radiomics feature extraction with deep learning architectures, including a Vision State-Space (VMamba) module for global-local feature representation and a Multi-Gate Mixture-of-Experts (MMoE) framework for multi-task learning. The model is designed to simultaneously perform disease classification and predict comorbidity risks (such as metabolic syndrome, hepatic insulin resistance, and recurrence risk). Primary outcomes include characterization of ocular feature patterns associated with inflammatory skin diseases. Secondary outcomes include correlations between ocular image-derived features and clinical severity indices. Model performance will be evaluated using ROC curves, AUC, calibration analysis, and decision curve analysis. This study aims to provide an objective, digitalized, and clinically applicable ocular biomarker framework to support early diagnosis, risk stratification, and comorbidity screening in inflammatory skin diseases.
Interventions
- Other Questionnaire collection
During the study visit investigators will conduct face-to-face interviews and collect the questionnaire data, with confirmation from family members where appropriate.
Primary outcome measures
- A TCM ocular diagnostic feature spectrum [Time frame: 2026.03.05-2028.03.05]
Secondary outcome measures (1)
- Correlations (Spearman's rho) between ocular feature scores and clinical severity scales [Time frame: 2026.03.05-2028.03.05]
Eligibility criteria
Inclusion criteria
For patients with inflammatory skin disease:
Clinical diagnosis of one of the three target inflammatory skin diseases (psoriasis, atopic dermatitis, or urticaria).
Age ≥ 18 and ≤ 65 years, any sex.
Understands and signs informed consent.
For healthy controls:
Do not meet diagnostic criteria for any of the three inflammatory skin diseases above.
Age ≥ 18 and ≤ 65 years, any sex.
Understands and signs informed consent.
Exclusion criteria
For patients with inflammatory skin disease:
Exclude any subject meeting any of the following:
Refusal to undergo examinations.
Presence of acute/active infectious ocular disease (e.g., viral keratoconjunctivitis).
Corneal perforation or high-risk perforation where contact procedures cause severe photophobia, eye pain, inability to keep eyes open or fixate.
Nystagmus or other conditions that prevent fixation.
Pupillary non-dilation (e.g., posterior synechiae) that precludes fundus imaging.
Severe eyelid lesions (e.g., marked swelling, ectropion, entropion) that prevent globe exposure.
Participation in other clinical trials within the previous 3 months or concurrent participation in other interventional studies.
- Healthy control - exclusion criteria
Exclude any subject meeting any of the following:
Presence of other skin diseases that could affect study assessments (e.g., atopic dermatitis, urticaria, scabies).
Refusal to undergo examinations.
Acute/active infectious ocular disease (e.g., viral keratoconjunctivitis).
Corneal perforation or high-risk perforation that causes severe photophobia, eye pain, inability to keep eyes open or fixate during contact procedures.
Nystagmus or other reasons preventing fixation.
Pupillary non-dilation (e.g., posterior synechiae) that prevents fundus imaging.
Participation in other clinical studies within the previous 3 months or currently participating in other clinical trials.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07434076 · 2026-0220