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NCT Number: NCT07434076

Cross-Sectional Study for an Ocular Imaging-Based Predictive Model of Inflammatory Skin Diseases Grounded in Traditional Chinese Medicine

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire collection

Other

During the study visit investigators will conduct face-to-face interviews and collect the questionnaire data, with confirmation from family members where appropriate.

Primary outcomes

  1. A TCM ocular diagnostic feature spectrum

    Time frame: 2026.03.05-2028.03.05

    A TCM ocular diagnostic feature spectrum: overall prevalence and pattern combinations of ocular features in the psoriasis group.

    Incidence rates of characteristic ocular change

Secondary outcomes

  1. Correlations (Spearman's rho) between ocular feature scores and clinical severity scales

    Time frame: 2026.03.05-2028.03.05

    Correlations (Spearman's rho) between ocular feature scores and clinical severity scales: PASI, BSA, DLQI, VAS, EASI, UAS, and UCT

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Li, PhD

CONTACT

[email protected]

13661956326

Sponsors and collaborators

Lead sponsor

Shanghai Yueyang Integrated Medicine Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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