Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data

NCT07541651 | Not Yet Recruiting

• 1 other identifier: 202601
• Study Type: observational
• Target: 208,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project integrates multimodal eye data (CFP, OCT, OCTA) from 50,000 cases, brain MR data from 150,000 cases, and ICD diagnoses, medical orders, and test results from an eye-brain paired cohort of 8,000 cases to construct an eye-brain cross-modal mapping model and an eye-brain-systemic disease association model. It aims to clarify the quantitative associations between multimodal ocular features and brain structural and vascular characteristics as well as systemic disease ICD diagnoses, thereby uncovering the cross-organ and cross-modal linkage mechanisms between the eye and brain. Ultimately, it seeks to achieve mapping and prediction of brain imaging features based on ocular data, enable ocular-based diagnosis and prediction of various diseases, and contribute significantly to early disease screening, risk stratification, and optimization of clinical diagnosis and treatment.

Conditions

Cataract; Vitreous Hemorrhage; Diabetic Eye Diseases; Cerebral Small Vessel Disease; Cerebrovascular Stenosis

Outcome Measures

Primary Outcomes (3)

• Performance of Systemic Disease Prediction Models

  Age- and sex-stratified Area Under the Receiver Operating Characteristic Curve (AUC)

  From the time of model construction and consistency alignment during the study period to the end of the 12-month follow-up after study initiation.

• Model generalisation capability.

  Evaluated by Cohen's kappa coefficient across external independent cohorts.

  From the completion of model construction and consistency calibration during the study period to the end of the 12-month follow-up after study initiation.

• Eye-Brain Mapping Model Performance.

  Measured by correlation coefficient between retinal imaging features and brain neuroimaging metrics.

  From the completion of model construction and consistency calibration during the study period to the end of the 12-month follow-up after study initiation.

Study Arms (4)

Ophthalmic Data Cohort

Other: No interventions were involved in this study.

Cerebral Data Cohort

Other: No interventions were involved in this study.

Oculo-Cerebral Matched Cohort

Other: No interventions were involved in this study.

Clinical Correlation Cohort

Other: No interventions were involved in this study.

Interventions

No interventions were involved in this study. OTHER

No interventions were involved in this study.

Cerebral Data Cohort; Clinical Correlation Cohort; Oculo-Cerebral Matched Cohort; Ophthalmic Data Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

(1) Ophthalmic Data Cohort: Patients and health check-up participants who underwent CFP , OCT or OCTA examinations at Beijing Friendship Hospital, Capital Medical University, from January 2009 to September 2025.(2) Cerebral Data Cohort: Patients and health check-up participants who underwent cerebral MR (Magnetic Resonance) examinations at the same hospital during the corresponding period.(3) Oculo-Cerebral Matched Cohort: Individuals from Beijing Friendship Hospital, Capital Medical University and the UK Biobank (UKB) database who had any of the above ophthalmic imaging examinations, plus cerebral MR scans, and could be matched with complete clinical information.(4) Clinical Correlation Cohort: Individuals from the above cohorts who had complete ICD (International Classification of Diseases) diagnoses, laboratory test results (including blood glucose, blood lipids, uric acid, etc.) and medical order records at Beijing Friendship Hospital, Capital Medical University.

You may qualify if:

• Eye data: Images must meet quality standards (no significant artifacts, key structures clearly visible), with complete examination records (including examination date and device model).
• Brain data: MR images must be free of motion artifacts, with complete sequences (at least including T1-weighted imaging and MRA), and reports must confirm no technical issues.
• Eye-brain paired cohort: Must contain at least one type of eye image (including CFP, OCT, or OCTA) along with brain MR data, and be linkable to a unique identifier and clinical information in the database
• Clinical data: Clinical information (such as core biochemical indicators, demographic information, and necessary questionnaire items) must have a missing rate ≤30%, with standardized and clear ICD diagnostic codes, complete laboratory test data, and medical order information (including medication or follow-up recommendations)

You may not qualify if:

• Ocular examinations in which key features cannot be identified due to conditions such as cataracts or vitreous hemorrhage brain MR images deemed unacceptable in quality due to factors such as metal implants
• Clinical information (including core biochemical indicators, demographic details, essential questionnaire items, etc.) with a missing rate exceeding 30%
• Individuals who are pregnant or lactating, those with ocular trauma, congenital ocular malformations, or severe organic diseases.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

MeSH Terms

Conditions

Cataract; Vitreous Hemorrhage; Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: April 21, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-02