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Status unknownNCT05223712Updated Feb 4, 2022

Artificial Intelligence System for the Detection and Prediction of Kidney Diseases Using Ocular Information

An observational study in Artificial Intelligence, Ophthalmology and Kidney Diseases, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-04.

Sponsored by Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
4,000
Ages
18 Years and older
Sex
All
01

Study summary

This is an retrospective and prospective multicenter study to develop and validate an artificial intelligent (AI) aided diagnosis, therapeutic effect assessment model including chronic kidney disease (CKD) and dialysis patients starting from April 2009, which is based on ophthalmic examinations (e.g. retinal fundus photography, slit-lamp images, OCTA, etc.) and CKD diagnostic and therapeutic data (routine clinical evaluations and laboratory data), to provide a reliable basis and guideline for clinical diagnosis and treatment.

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Conditions studied

  • Artificial Intelligence
  • Ophthalmology
  • Kidney Diseases

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Keywords

  • Kidney Diseases
  • Artificial Intelligence
  • Eye information
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Participants who had slit-lamp, retinal fundus photography and kidney disease tests at the Department of Nephrology, First Affiliated Hospital of Sun Yat-sen University and Medical Centre of Aikang Health Care, Guangzhou, China

Inclusion criteria

  • Patients previously received kidney biopsy, ophthalmic examinations and routine examinations of the department of nephrology during in-hospital period with BCVA>0.5.

Exclusion criteria

Exclusion Criteria:

  • Patients without retinal fundus images or kidney diseases.
  • The quality of the retinal fundus images can not meet the requirement for furthur analysis.
  • Severe loss of results of routine examinations of the department of nephrology.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
4,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Development Dataset 01

    Slit-lamp, retinal fundus images, OCTA and kidney diseases examinations collected from Department of Nephrology of the First Affiliated Hospital of Sun Yat-sen University

    Other: Diagnostic Test: Chronic Kidney Diseases

  • Development Dataset 02

    Slit-lamp, retinal fundus images, OCTA and kidney diseases examinations collected from Medical Centre of Aikang Health Care, Guangzhou, China

    Other: Diagnostic Test: Chronic Kidney Diseases

  • Validation Dataset 01

    Slit-lamp, retinal fundus images, OCTA and kidney diseases examinations collected from Department of Nephrology of the First Affiliated Hospital of Sun Yat-sen University

    Other: Diagnostic Test: Chronic Kidney Diseases

  • Validation Dataset 02

    Slit-lamp, retinal fundus images, OCTA and kidney diseases examinations collected from Medical Centre of Aikang Health Care, Guangzhou, China

    Other: Diagnostic Test: Chronic Kidney Diseases

  • Test Dataset 01

    Slit-lamp, retinal fundus images, OCTA and kidney diseases examinations collected from Department of Nephrology of the First Affiliated Hospital of Sun Yat-sen University

    Other: Diagnostic Test: Chronic Kidney Diseases

  • Test Dataset 02

    Slit-lamp, retinal fundus images, OCTA and kidney diseases examinations collected from Medical Centre of Aikang Health Care, Guangzhou, China

    Other: Diagnostic Test: Chronic Kidney Diseases

Interventions

  • OtherDiagnostic Test: Chronic Kidney Diseases

    The development datasets were used to train the deep learning model, which was validated and tested by the other 4 datasets.

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What researchers measure

Primary outcomes

  1. Area under the receiver operating characteristic curve of the deep learning system

    The investigators will calculate the area under the receiver operating characteristic curve of deep learning system and compare this index between deep learning system and human doctors

    Time frame: baseline

Secondary outcomes

  1. Sensitivity and specificity of the deep learning system

    The investigators will calculate the sensitivity and specifity of deep learning system and compare this index between deep learning system and human doctors

    Time frame: baseline

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Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05223712
Lead sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Haotian Lin (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Feb 4, 2022
Start date
Aug 28, 2021
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Feb 4, 2022

Study contacts

Haotian Lin, Ph. D
Contact
gddlht@aliyun.com
13802793086
Yizhi Liu, M.D., Ph.D.
study chair · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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