dry eye
Conditions
Interventions
None listed
Sponsors
Yamaguchi Masahiro
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 (8)) is used as the test method. | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 (18) Sensitivity and specificity of the test method to dry eye diagnosis using the standard method (diagnosis of dry eye using DEA01 (J-OSDI 13 points or more and within the MBI cutoff value set for secondary evalu | — |
Contacts
Public ContactTakenori Inomata
Juntendo University Hospital
Outcome results
None listed