Telemedicine Evaluation of Dry Eye Disease Using a Portable Automatic Ocular Surface Imaging Device (PAOSID)

This study aims to evaluate the diagnostic accuracy and grading consistency of a mobile phone-attached portable automatic ocular surface imaging device (PAOSID) for assessing dry eye disease (DED). Both patients diagnosed with DED and healthy volunteers will undergo conventional clinical imaging, including white-light anterior segment photography, corneal fluorescein staining (CFS) under cobalt blue light, and tear film break-up time (TBUT), all performed under slit-lamp examination, as well as meibography. Clinical grading of DED severity will follow the TFOS DEWS I criteria, while other ocular surface findings-such as conjunctival injection, meibomian gland area loss, and CFS-will be assessed using standard ocular surface disease scoring scales. Following the clinical assessment, participants will use the PAOSID device to independently capture similar ocular surface images and videos. These remote images and videos will first be used to determine whether the participant has dry eye disease (DED). Regardless of the diagnosis result, all participants will undergo severity grading based on the TFOS DEWS I criteria, along with standardized scoring of ocular surface conditions such as conjunctival injection, meibomian gland area loss, and corneal fluorescein staining (CFS). The study will compare remote and clinical assessments to evaluate diagnostic agreement and grading consistency, and assess patient satisfaction and usability of the PAOSID system.

NCT Number	NCT06984549
Lead Sponsor	Chen Wei Collaborators: Singapore National Eye Centre, University of Sydney
Conditions	Dry Eye Disease (DED)
Enrollment	150 participants
Start Date	2025-03-01
Primary Completion	2025-10-01 (estimated)
Study Completion	2025-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-22