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Status unknownNCT03899623Updated Apr 2, 2019

Multi-modal Imaging and Artificial Intelligence Diagnostic System for Multi-level Clinical Application

An observational study in Diabete Mellitus and Diabetic Retinopathy, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
3,000
Sex
All
01

Study summary

This study is to build an multi-modal artificial intelligence ophthalmological imaging diagnostic system covering multi-level medical institutions. We are going to evaluate this system in an evidence-based medicine view, taking diabetic retinopathy as an example. And clinical diagnostic criteria will be made based on this multi-modal artificial intelligence imaging diagnostic system. The study is designed as a cross-sectional study involving 1,000 normal individuals, 1,000 diabetes patients without ocular complications, and 1,000 with diabetic ocular complications. Statistical analysis of the diagnostic sensitivity and specificity of the artificial intelligence system will be made, and ROC curve wil be draw.

02

Conditions studied

  • Diabete Mellitus
  • Diabetic Retinopathy

Keywords

  • Diabete Mellitus
  • Diabetic Retinopathy
  • Artificial Intelligence
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Stratified sampling

Inclusion criteria

Group A(normal individuals): Meet all the items 1 \~ 5 below

  1. No familial or hereditary retinopathy;
  2. No history of ocular trauma and / or history of ocular disease (except for mild to moderate refractive errors and / or age-related cataracts);
  3. No drug use history that may cause side effects of retina (such as chloroquine, hydroxychloroquine, chlorpromazine, rifampin, etc.); 4 binocular diopter ≤ ± 6.00D; No systemic diseases that may affect the retina.

Group B(diabetes patients without ocular complications): meet any of 1 to 3, and both 4 to 5 items

  1. Diagnosed with type 1 diabetes for more than 5 years;
  2. Diagnosed with type 2 diabetes patients;
  3. Diagnosis of gestational diabetes patients;
  4. Without systemic disease that may affect the retina except for diabetes;
  5. Meet the standards of 1 to 4 items.

Group C(patients with diabetic ocular complications): meet with any of 1 to 3, and all 4 to 6 items

  1. Diagnosed with type 1 diabetes for more than 5 years;
  2. Diagnosed with type 2 diabetes patients;
  3. Diagnosis of gestational diabetes patients;
  4. Meet the guidelines for diagnosis and treatment of diabetic retinopathy in any stage of diabetic retinopathy and / or diabetic macular edema.
  5. Without systemic disease that may affect the retina except for diabetes;
  6. A group to meet the criteria for 1 to 4 items.

Exclusion criteria

Exclusion Criteria:

  1. Refractive pathway is turbid, so that fundus image can not be clearly photographed;
  2. With other fundus diseases and / or other diseases that seriously affect the visual function;
  3. Any eye infection, such as conjunctivitis, keratitis, scleritis, endophthalmitis, acute and chronic dacryocystitis, or eye injury;
  4. Serious systemic diseases such as diabetes, hypertension, heart failur,renal failure;
  5. Can not cooperate with the examiner due to mental or other reasons.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
3,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The diagnostic sensitivity, specificity and ROC curve of the artificial intelligence(AI) system compared with reference standard (ophthalmologist).

    Sensitivity: the percentage of diabetic retinopathy(DR) patients who are correctly identified as having the condition by AI. Sensitivity=True positive/(True positive+False negative). Specificity: the percentage of healthy people who are correctly identified as not having the condition by AI. Specificity=True negative /(True negative +False positive). The ROC curve was plotted with true positive rate (sensitivity) as the ordinate and false positive rate (1-specificity) as the abscissa.

    Time frame: It will take 15~20min for each subject to take the exams.

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Opthalmic Center
    Guangzhou, Guangdong 510000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03899623
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Jin Yuan (Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Apr 2, 2019
Start date
Apr 23, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Apr 2, 2019

Study contacts

Yuan Jin, Professor
Contact
yuanjincornea@126.com
8602087333391
Yuan Jin, Professor
principal investigator · Zhongshan Opthalmic Center

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 Mar 2019. You cannot join it, but the record below documents what was studied.

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