Evaluate the Dry Eye diagnostic ability of the Smartphone application.

Phase 2

Recruiting

• Conditions: dry eye; Dry Eye Syndromes

• Registration Number: JPRN-jRCTs032220524
• Lead Sponsor: Yamaguchi Masahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-21
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

(1) Patients with dry eye or suspected dry eye who visit the outpatient ophthalmology clinic of the institution where the study is conducted
(2) Patients who are 16 years of age or older at the time consent is obtained
(3) Patients who are able to use smartphones
(4) Patients who have given their or their surrogate's (person with parental authority) free and voluntary written consent.

Exclusion Criteria

(1) Patients with a history of disorders affecting the blinking eye such as eyelid closure disorder, ptosis, psychiatric disorders, Parkinson's disease, etc.
(2) Patients who came to the hospital wearing contact lenses on the day consent was obtained
3) Patients who are unable to comply with the research protocol and follow-up (due to mental, familial, social, geographical, etc. reasons)
(4) Other patients who are deemed inappropriate as research subjects by the principal investigator and the subinvestigators.

Study & Design

• Study Type: Other
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the test method*2 to dry eye diagnosis using the standard method*1<br>*1: Dry eye diagnosis based on dry eye diagnostic criteria (J-OSDI 13 points or more and TFBUT within 5 seconds) is the standard method.<br>2: Dry eye diagnosis by DEA01 (J-OSDI 13 points or more and within the MBI cut-off value set in the secondary endpoint (5)) is used as the test method.