Dry Eye Screening and Referral System

NCT04413370 | Unknown DMC

• 1 other identifier: Dry eye screening system
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Area under the curve (severe)

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

  up to 1 month

Secondary Outcomes (2)

• Area under the curve (each group)

  up to 1 month

• Accuracy, true positive rate, and true negative rate

  up to 1 month

Study Arms (3)

Severe Group

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

Diagnostic Test: Dry eye diagnostic test

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

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

Interventions

Dry eye diagnostic test DIAGNOSTIC_TEST

The artificial intelligent dry eye screening platform

Follow-up group; Mild group; Severe Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510632, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: January 6, 2020
• Primary Completion: April 19, 2022
• Study Completion: August 1, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)