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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Other: Questionnaire collection

• Study Type: Observational
• Enrollment (Estimated): 950

Contacts and Locations

• Study Contact: Name: Xin Li, PhD; Phone Number: 13661956326; Email: 13661956326@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

As an exploratory cross-sectional study involving high-dimensional image-omics modeling, we plan to enlarge the sample size. We intend to recruit 200 cases each of psoriasis, atopic dermatitis, and urticaria, and 150 healthy controls. The dataset will be split into training and internal validation sets at an 8:2 ratio. An external independent validation cohort of 200 subjects is planned. The total sample size is therefore approximately 950 participants.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	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.
Psoriasis subjects	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.
Atopic dermatitis subjects	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.
Urticaria subjects	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A TCM ocular diagnostic feature spectrum	A TCM ocular diagnostic feature spectrum: overall prevalence and pattern combinations of ocular features in the psoriasis group. Incidence rates of characteristic ocular change	2026.03.05-2028.03.05

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations (Spearman's rho) between ocular feature scores and clinical severity scales	Correlations (Spearman's rho) between ocular feature scores and clinical severity scales: PASI, BSA, DLQI, VAS, EASI, UAS, and UCT	2026.03.05-2028.03.05

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 5, 2026
• Primary Completion (Estimated): March 5, 2028
• Study Completion (Estimated): May 25, 2028

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Psoriasis; Dermatitis, Atopic
• Other Study ID Numbers: 2026-0220

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