ArticleJMIR research protocols2023
Diagnostic Ability of a Smartphone App for Dry Eye Disease: Protocol for a Multicenter, Open-Label, Prospective, and Cross-sectional Study.
Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 16 citations in OpenAlex.
- Virtual Reality-Based Program for Pediatric Patients With Amblyopia: Protocol for a Multicenter, Randomized, Open-Label, Two-Arm Study.JMIR research protocols · 2026Article
- Integration of Digital Phenotyping and Genomics for Dry Eye Disease: Protocol for a Prospective Cohort Study.JMIR research protocols · 2025Article
- Patients' knowledge, attitudes, and practices regarding lifestyle related dry eye.Scientific reports · 2025Article
- Minimal Clinically Important Differences With the Outcomes of the App-Based Japanese Allergic Conjunctival Diseases Quality of Life Questionnaire: Cross-Sectional Observational Study.JMIR formative research · 2024Observational
- A Medical Paradigm Shift in Society 5.0: Implementation of a Smartphone App-based Dry Eye Diagnosis Assistance Software as a Medical Device.Juntendo Iji zasshi = Juntendo medical journal · 2024Article
- Design and Usability Study of a Point of Care mHealth App for Early Dry Eye Screening and Detection.Journal of clinical medicine · 2023Article
- Clinical utility of maximum blink interval measured by smartphone application DryEyeRhythm to support dry eye disease diagnosis.Scientific reports · 2023Observational
- Interobserver Reliability of Tear Break-Up Time Examination Using "Smart Eye Camera" in Indonesian Remote Area.Clinical ophthalmology (Auckland, N.Z.) · 2023Article
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Authors and funding
28 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDry 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.
objectiveThis study aimed to evaluate the capabilities of the DEA01 smartphone app to facilitate a DED diagnosis.
methodsIn 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.
resultsPatient 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.
conclusionsThis 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 registrationJapan Registry of Clinical Trials jRCTs032220524; https://jrct.niph.go.jp/latest-detail/jRCTs032220524. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45218.
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