CataractNCT07541651
Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data
An observational study of Cataract and Vitreous Hemorrhage, run by Beijing Friendship Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract, Vitreous Hemorrhage, Diabetic Eye Diseases
- How many people
- 208,000 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
- Prior to initial inclusion in the study, participants must have no history of severe organic diseases (including non-curable or end-stage malignancies, severe heart failure (NYHA Class III-IV), end-stage renal disease (CKD Stage 5), decompensated cirrhosis, or significant functional impairment due to severe cerebrovascular disease sequelae, etc.).
Who cannot join
- 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.
About this study
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
- Being tested
- No interventions were involved in this study.
- Medical subject headings
- Cataract, Vitreous Hemorrhage, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions were involved in this study.Other
No interventions were involved in this study.
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmic Data Cohort | Not described Receives: Other: No interventions were involved in this study. | |
| Cerebral Data Cohort | Not described Receives: Other: No interventions were involved in this study. | |
| Oculo-Cerebral Matched Cohort | Not described Receives: Other: No interventions were involved in this study. | |
| Clinical Correlation Cohort | Not described Receives: Other: No interventions were involved in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Systemic Disease Prediction Models
Age- and sex-stratified Area Under the Receiver Operating Characteristic Curve (AUC)
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start25 Dec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541651
- Sponsor's protocol ID
- 202601
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data
- ClinicalTrials.gov ID
- NCT07541651
- Acronym / sponsor ID
- 202601
- Conditions
- Cataract, Vitreous Hemorrhage, Diabetic Eye Diseases, Cerebral Small Vessel Disease, Cerebrovascular Stenosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 208,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 25 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
- Prior to initial inclusion in the study, participants must have no history of severe organic diseases (including non-curable or end-stage malignancies, severe heart failure (NYHA Class III-IV), end-stage renal disease (CKD Stage 5), decompensated cirrhosis, or significant functional impairment due to severe cerebrovascular disease sequelae, etc.).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions were involved in this study.No interventions were involved in this study. | Other | Cerebral Data Cohort, Clinical Correlation Cohort, Oculo-Cerebral Matched Cohort, Ophthalmic Data Cohort |
Primary outcome
Performance of Systemic Disease Prediction Models
Time frame: 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.
Age- and sex-stratified Area Under the Receiver Operating Characteristic Curve (AUC)
Model generalisation capability.
Time frame: 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.
Evaluated by Cohen's kappa coefficient across external independent cohorts.
Eye-Brain Mapping Model Performance.
Time frame: 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.
Measured by correlation coefficient between retinal imaging features and brain neuroimaging metrics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Vitreous Hemorrhage, run by Beijing Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Systemic Disease Prediction Models (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.