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

Recruitingn/aAges 18 Years - anyAllChen Wei
NCT06984549 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Participants included individuals with dry eye, based on the TFOS DEWS II (The Tear Film and Ocular Surface Society Dry Eye Workshop II) guidelines,(19) as well as relatively healthy individuals with no ocular conditions who voluntarily agreed to participate in the study. 2. Participants, or their companions or caregivers, who are willing and able to use the study smartphone to capture relevant eye images and videos. 3. Aged 18 years or older. 4. Provide informed consent. Exclusion Criteria: 1. Participants with ocular surface disorders other than DED that may affect the appearance of the ocular surface (e.g., pterygium, keratitis, corneal scarring) or with any organic pathologies impacting vision (e.g., cataracts, glaucoma, retinal diseases). 2. Patients currently wearing scleral lenses or bandage contact lenses. 3. Unable to cooperate with the PAOSID, such as due to a serious mental illness or brain damage causing loss of limb control. 4. Significant changes in the ocular images since diagnosis due to factors such as postdiagnostic treatment. Eye selection criteria
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What it tests

  • DED diagnosis using PAOSID
  • DED diagnosis using slit lamp
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Where

1 site
The Eye Hospital, Wenzhou Medical University
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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