Design of a mobile application and evaluation of its effects on clinical outcomes in patients with dry eye disease: a...

Dry eye is a common ocular surface disorder resulting from tear deficiency or excess tear evaporation. This protocol will be implemented for a study designed to determine the effectiveness of a mobile self-care application on objective clinical test results and subjective symptoms in patients with dry eye disease.

The first stage will include the development of a mobile self-care application using the Python framework of Flask technology and SQLite database in the backend, and the Flutter framework of Dart for the bot technology in the front end. The second stage will be conducted using a two-arm blinded randomized clinical trial. The sample size calculation initially targeted 104 patients with dry eye disease, intended for division into intervention and control groups via an online random number generator. However, unforeseen challenges, including COVID-19 disruptions, led to randomization of 181 patients (91 intervention, 90 control).This resulted in 104 completers after a 42.5% dropout rate. Patients in both groups will receive usual medical care, but those in the intervention group will also use a mobile-based application for a period of 12 weeks. Study outcomes including the Tear Break-Up Time clinical test as the primary outcome, and the validated Persian version of the Ocular Surface Disease Index questionnaire as a secondary outcome measure in patients with dry eye disease, will be assessed at 6- and 12-weeks post-baseline.

It is expected that delivering customized training via a mobile application during clinical visits would promote improvement and reduction of disease severity, as well as strengthen the physician-patient relationship. This study was developed by an interdisciplinary research team in accordance with current dry eye disease guidelines and taking into account the medical history and classification of dry eye disease. Considering the lack of financial resources for traditional self-care methods and the development of technologies based on mobile health, it seems that one can hope for the acceptance of such systems in the patients with dry eyes.

This protocol is registered in the Iranian registration of clinical trial (IRCT) with the code IRCT20200721048162N1. Registered 31 August 2020, URL: https://irct.behdasht.gov.ir/trial/49779 .