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Clinical Trials/NCT04413370
NCT04413370CompletedNot Applicable

The Development of Artificial Intelligence Dry Eye Screening and Referral System

Sun Yat-sen University1 site in 1 country1,273 target enrollmentStarted: January 6, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,273
Locations
1
Primary Endpoint
Area under the curve (severe)

Study Overview

Brief Summary

Dry eye is one of the most common ocular surface diseases. Its pathogenic factors are related to multiple etiology. Because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher requirements on the professional technology and examination equipment of ophthalmologists.

The purpose of this study is to establish a case-control cohort of dry eye patients. Multimodal data will be collected from participants, including medical history information, ocular surface disease index scale (OSDI), anterior segment photography, and treatment outcome of dry eye patients. The correlation between the characteristics of anterior segment images and dry eye diagnosis will be explored by artificial intelligence algorithms. The purpose of this study was to develop an artificial intelligence dry eye screening and referral system.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Subjects whose age are greater than or equal to 18 years old;
  • •Subjects who can cooperate with the inspection;
  • •Subjects who agree to participate in the study and sign the consent form.

Exclusion Criteria

  • •Subjects who cannot do the inspection.
  • •Subjects who suffer from diseases that compromise the inspection.

Arms & Interventions

Mild group

This group of subjects was diagnosed with dry eye but can use artificial tears instead of further treatment.

Intervention: Dry eye diagnostic test (Diagnostic Test)

Follow-up group

This group of subjects had no dry eye symptoms and signs and belonged to the normal control group.

Intervention: Dry eye diagnostic test (Diagnostic Test)

Severe Group

This group of subjects needed a referral to the hospital for further treatments.

Intervention: Dry eye diagnostic test (Diagnostic Test)

Outcomes

Primary Outcomes

Area under the curve (severe)

Time Frame: up to 1 month

AUC values for predicting whether subject need to be referral or not.

Secondary Outcomes

  • Area under the curve (each group)(up to 1 month)
  • Accuracy, true positive rate, and true negative rate(up to 1 month)

Investigators

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haotian Lin

Professor

Sun Yat-sen University

Study Sites (1)

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