An observational study in Dry Eye Disease (DED), sponsored by Chen Wei. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Chen Wei · Observational
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.
Multicenter, Cross-sectional
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 150 is above the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Chen Wei as lead sponsor.
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The study population includes patients clinically diagnosed with dry eye disease (DED) and age-matched healthy volunteers. All participants undergo both PAOSID-based and slit-lamp-based ocular surface imaging for diagnostic and grading comparison.
Exclusion Criteria:
Eye selection criteria
Other: DED diagnosis using PAOSID · Other: DED diagnosis using slit lamp
Other: DED diagnosis using PAOSID · Other: DED diagnosis using slit lamp
A non-invasive diagnostic approach using the Portable Automatic Ocular Surface Imaging Device (PAOSID) to capture anterior segment images and videos for the assessment of dry eye disease (DED).
A non-invasive diagnostic approach using the slit lamp to capture anterior segment images and videos for the assessment of dry eye disease (DED).
Agreement between PAOSID-based and slit-lamp-based DED diagnosis
Time frame: At baseline (Day 0)
Plan to share: Undecided
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