Dry Eye Screening and Referral System

Dry Eye Clinical Trial

Official title:

The Development of Artificial Intelligence Dry Eye Screening and Referral System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04413370
• Other study ID #: Dry eye screening system
• Status: Active, not recruiting
• Start date: January 6, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: April 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 518
• Est. completion date: August 1, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Diagnostic Test:
• Dry eye diagnostic test
The artificial intelligent dry eye screening platform

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (severe)	AUC values for predicting whether subject need to be referral or not.	up to 1 month
Secondary	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
Secondary	Accuracy, true positive rate, and true negative rate	The performance of this artificial platform.	up to 1 month