TY - JOUR AU - Nagino, Ken AU - Okumura, Yuichi AU - Yamaguchi, Masahiro AU - Sung, Jaemyoung AU - Nagao, Masashi AU - Fujio, Kenta AU - Akasaki, Yasutsugu AU - Huang, Tianxiang AU - Hirosawa, Kunihiko AU - Iwagami, Masao AU - Midorikawa-Inomata, Akie AU - Fujimoto, Keiichi AU - Eguchi, Atsuko AU - Okajima, Yukinobu AU - Kakisu, Koji AU - Tei, Yuto AU - Yamaguchi, Takefumi AU - Tomida, Daisuke AU - Fukui, Masaki AU - Yagi-Yaguchi, Yukari AU - Hori, Yuichi AU - Shimazaki, Jun AU - Nojiri, Shuko AU - Morooka, Yuki AU - Yee, Alan AU - Miura, Maria AU - Ohno, Mizu AU - Inomata, Takenori PY - 2023 DA - 2023/3/13 TI - Diagnostic Ability of a Smartphone App for Dry Eye Disease: Protocol for a Multicenter, Open-Label, Prospective, and Cross-sectional Study JO - JMIR Res Protoc SP - e45218 VL - 12 KW - digital health KW - digital therapeutics KW - dry eye disease KW - Japanese version of the Ocular Surface Disease Index KW - maximum blink interval KW - mobile health KW - smartphone KW - smartphone app KW - tear film breakup time KW - telemedicine AB - 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 SN - 1929-0748 UR - https://www.researchprotocols.org/2023/1/e45218 UR - https://doi.org/10.2196/45218 UR - http://www.ncbi.nlm.nih.gov/pubmed/36912872 DO - 10.2196/45218 ID - info:doi/10.2196/45218 ER -