Diagnostic Ability of a Smartphone App for Dry Eye Disease: Protocol for a Multicenter, Open-Label, Prospective, and Cross-sectional Study

Author:

Nagino KenORCID,Okumura YuichiORCID,Yamaguchi MasahiroORCID,Sung JaemyoungORCID,Nagao MasashiORCID,Fujio KentaORCID,Akasaki YasutsuguORCID,Huang TianxiangORCID,Hirosawa KunihikoORCID,Iwagami MasaoORCID,Midorikawa-Inomata AkieORCID,Fujimoto KeiichiORCID,Eguchi AtsukoORCID,Okajima YukinobuORCID,Kakisu KojiORCID,Tei YutoORCID,Yamaguchi TakefumiORCID,Tomida DaisukeORCID,Fukui MasakiORCID,Yagi-Yaguchi YukariORCID,Hori YuichiORCID,Shimazaki JunORCID,Nojiri ShukoORCID,Morooka YukiORCID,Yee AlanORCID,Miura MariaORCID,Ohno MizuORCID,Inomata TakenoriORCID

Abstract

Background Dry eye disease (DED) is one of the most common ocular surface diseases. Numerous patients with DED remain undiagnosed and inadequately treated, experiencing various subjective symptoms and a decrease in quality of life and work productivity. A mobile health smartphone app, namely, the DEA01, has been developed as a noninvasive, noncontact, and remote screening device, in the context of an ongoing paradigm shift in the health care system, to facilitate a diagnosis of DED. Objective This study aimed to evaluate the capabilities of the DEA01 smartphone app to facilitate a DED diagnosis. Methods In this multicenter, open-label, prospective, and cross-sectional study, the test method will involve using the DEA01 smartphone app to collect and evaluate DED symptoms, based on the Japanese version of the Ocular Surface Disease Index (J-OSDI), and to measure the maximum blink interval (MBI). The standard method will then involve a paper-based J-OSDI evaluation of subjective symptoms of DED and tear film breakup time (TFBUT) measurement in an in-person encounter. We will allocate 220 patients to DED and non-DED groups, based on the standard method. The primary outcome will be the sensitivity and specificity of the DED diagnosis according to the test method. Secondary outcomes will be the validity and reliability of the test method. The concordance rate, positive and negative predictive values, and the likelihood ratio between the test and standard methods will be assessed. The area under the curve of the test method will be evaluated using a receiver operating characteristic curve. The internal consistency of the app-based J-OSDI and the correlation between the app-based J-OSDI and paper-based J-OSDI will be assessed. A DED diagnosis cutoff value for the app-based MBI will be determined using a receiver operating characteristic curve. The app-based MBI will be assessed to determine a correlation between a slit lamp–based MBI and TFBUT. Adverse events and DEA01 failure data will be collected. Operability and usability will be assessed using a 5-point Likert scale questionnaire. Results Patient enrollment will start in February 2023 and end in July 2023. The findings will be analyzed in August 2023, and the results will be reported from March 2024 onward. Conclusions This study may have implications in identifying a noninvasive, noncontact route to facilitate a diagnosis of DED. The DEA01 may enable a comprehensive diagnostic evaluation within a telemedicine setting and facilitate early intervention for undiagnosed patients with DED confronting health care access barriers. Trial Registration Japan Registry of Clinical Trials jRCTs032220524; https://jrct.niph.go.jp/latest-detail/jRCTs032220524 International Registered Report Identifier (IRRID) PRR1-10.2196/45218

Publisher

JMIR Publications Inc.

Subject

General Medicine

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