Evaluate the Dry Eye diagnostic ability of the Smartphone application.

JRCT ID: jRCTs032220524

Registered date:21/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: dry eye
• Date of first enrollment: 10/05/2023
• Target sample size: 264
• Study type: Other

Outcome(s)

Primary Outcome

Sensitivity and specificity of the test method*2 to dry eye diagnosis using the standard method*1
*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.
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.

Secondary Outcome

(1) Overall agreement rate of test methods for dry eye diagnosis by the standard method.
(2) Positive and negative likelihood ratios of test methods for dry eye diagnosis by the standard method
(3) Positive likelihood ratio/negative likelihood ratio of test methods for dry eye diagnosis by the standard method
(4) Area under the ROC curve (AUC) of dry eye diagnosis by the test method compared to dry eye diagnosis by the standard method using ROC analysis
(5) Cut-off value of MBI in the test method for dry eye diagnosis by the standard method using ROC analysis.
(6) Area under the ROC curve (AUC) of MBI in the test method for dry eye diagnosis by the standard method using ROC analysis
(7) Area under the ROC curve (AUC) of dry eye diagnosis by the test method for TFBUT less than 5 seconds by ROC analysis
(8) Cut-off value of MBI of the test method for TFBUT of 5 seconds or less by ROC analysis
(9) Area under the ROC curve (AUC) of MBI by the test method for TFBUT of 5 seconds or less by ROC analysis
(10) Internal consistency of J-OSDI measurement results of the test method
(11) Correlation, comparison and concordance between J-OSDI measurement results of standard methods and J-OSDI measurement results of test methods.
(12) Correlation, comparison and agreement between measured MBI values (measured by visual MBI measurement and MBI measurement by slit-lamp microscopy) and MBI results of the test method.
(13)Correlation, comparison and concordance between actual measured values of MBI (measured by visual MBI measurements and MBI measurements by slit-lamp microscopy) with TFBUT
(14)Correlation and comparison of measured MBI results of TFBUT and test methods.
(15) DEA01 operability evaluation
(16) Occurrence of adverse events
(17) Investigation of DEA01 failures

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamaguchi Masahiro
• Source(s) of Monetary Support: InnoJin, Inc.