Dry Eye Screening and Referral System

The Development of Artificial Intelligence Dry Eye Screening and Referral System

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 Overview

• Status: Active, not recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Diagnostic test: Dry eye diagnostic test

• Study Type: Observational
• Enrollment (Actual): 518

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510632
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects who are equal or over 18 years old with or without dry eye symptoms and signs.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe Group; This group of subjects needed a referral to the hospital for further treatments.	Diagnostic test: Dry eye diagnostic test; The artificial intelligent dry eye screening platform
Mild group; This group of subjects was diagnosed with dry eye but can use artificial tears instead of further treatment.	Diagnostic test: Dry eye diagnostic test; The artificial intelligent dry eye screening platform
Follow-up group; This group of subjects had no dry eye symptoms and signs and belonged to the normal control group.	Diagnostic test: Dry eye diagnostic test; The artificial intelligent dry eye screening platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (severe)	AUC values for predicting whether subject need to be referral or not.	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (each group)	AUC values for predicting whether subject can be accurately grouped into each of the four groups.	up to 1 month
Accuracy, true positive rate, and true negative rate	The performance of this artificial platform.	up to 1 month

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): April 19, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: Dry eye screening system

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No