Dry Eye Screening and Referral System

Sponsor
Sun Yat-sen University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04413370
Collaborator
(none)
518
1
30.8
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Dry eye diagnostic test

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
518 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Development of Artificial Intelligence Dry Eye Screening and Referral System
Actual Study Start Date :
Jan 6, 2020
Actual Primary Completion Date :
Apr 19, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Area under the curve (severe) [up to 1 month]

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

Secondary Outcome Measures

  1. Area under the curve (each group) [up to 1 month]

    AUC values for predicting whether subject can be accurately grouped into each of the four groups.

  2. Accuracy, true positive rate, and true negative rate [up to 1 month]

    The performance of this artificial platform.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center Guangzhou Guangdong China 510632

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04413370
Other Study ID Numbers:
  • Dry eye screening system
First Posted:
Jun 2, 2020
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Apr 25, 2022