Actively Recruiting

Age: 18Years +
All Genders
NCT06984549

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

Led by Chen Wei · Updated on 2025-05-22

150

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

C

Chen Wei

Lead Sponsor

S

Singapore National Eye Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Individuals diagnosed with dry eye disease using TFOS DEWS II guidelines or healthy individuals without ocular conditions
  • Participants or their caregivers willing and able to use a smartphone to capture eye images and videos
  • Participants who provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of ocular surface disorders other than dry eye that affect eye appearance (e.g., pterygium, keratitis, corneal scarring)
  • Presence of organic eye diseases affecting vision (e.g., cataracts, glaucoma, retinal diseases)
  • Currently wearing scleral lenses or bandage contact lenses
  • Inability to cooperate with the PAOSID device due to serious mental illness or brain damage affecting limb control
  • Significant changes in ocular images since diagnosis caused by postdiagnostic treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

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Research Team

R

Ruobing Xia

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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