Multimodal Machine Learning for Auxiliary Diagnosis of Eye Diseases

Sponsor
Eye & ENT Hospital of Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05930444
Collaborator
The Affiliated Eye Hospital of Nanjing Medical University (Other), Suqian First People's Hospital (Other)
2,000
3
4
666.7
166.3

Study Details

Study Description

Brief Summary

With rapid advancements in natural language processing and image processing, there is a growing potential for intelligent diagnosis utilizing chatGPT trained through high-quality ophthalmic consultation. Furthermore, by incorporating patient selfies, eye examination photos, and other image analysis techniques, the diagnostic capabilities can be further enhanced. The multi-center study aims to develop an auxiliary diagnostic program for eye diseases using multimodal machine learning techniques and evaluate its diagnostic efficacy in real-world outpatient clinics.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Multimodal Machine Learning Program for Auxiliary Diagnosis of Eye Diseases

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Multimodal Machine Learning for Auxiliary Diagnosis of Eye Diseases Using ChatGPT-based Natural Language Processing and Image Processing Techniques
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Normal participants

Healthy individuals who have no concerns related to their eyes.

Patients with Eye-related Chief Complaints

Individuals who have specific concerns or issues related to their eyes, which they consider as the main reason for seeking medical attention or making a complaint.

Diagnostic Test: Multimodal Machine Learning Program for Auxiliary Diagnosis of Eye Diseases
Patients presenting with eye-related chief complaints initially complete a mobile phone application. This application utilizes patient medical history and relevant images (such as selfies and photos from eye examinations) to provide intelligent diagnosis. The diagnosis remains undisclosed to the patients. Subsequently, patients seek medical attention and undergo clinical examination by a skilled clinician. The clinical diagnosis is subsequently reviewed by a second experienced clinician. If the diagnoses align, it is considered the gold standard. In cases of discrepancy, the consensus reached by the two clinicians becomes the gold standard.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of multimodal machine learning program [from July 2023 to October 2023]

    For each patient, the diagnoses generated by the multimodal machine learning program and the clinical diagnosis provided by skilled clinicians were documented and compared. Consistency between the two diagnoses indicates the program's precision in clinical practice.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Informed consent obtained;

  • Participants should be able to have Chinese as their mother tongue, and be sufficiently able to read, write and understand Chinese;

  • For normal participants: individuals should have no concerns related to their eyes.

  • For participants with eye-related chief complaints: individuals should have specific concerns or issues related to their eyes.

Exclusion Criteria:
  • Incomplete clinical data to support final diagnosis;

  • Patients who, in the opinion of the attending physician or clinical study staff, are too medically unstable to participate in the study safely.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Affiliated Eye Hospital of Nanjing Medical University Nanjing China
2 Fudan Eye & ENT Hospital Shanghai China
3 Suqian First People's Hospital Suqian China

Sponsors and Collaborators

  • Eye & ENT Hospital of Fudan University
  • The Affiliated Eye Hospital of Nanjing Medical University
  • Suqian First People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT05930444
Other Study ID Numbers:
  • FD-EENT-20230625
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023