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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04413370
Other study ID # Dry eye screening system
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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