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Recruiting NCT06984549

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

— Observational Dry Eye Disease (DED)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DED diagnosis using PAOSID, DED diagnosis using slit lamp.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Telemedicine for Evaluating Dry Eye Disease (DED) Using a Mobile Phone-Attached Portable Automatic Ocular Surface Imaging Device (PAOSID): A Patient-Operated Diagnostic and Continuous Ocular Surface Monitoring (COSM) System

Overview

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.

Detailed description

Multicenter, Cross-sectional

Interventions

  • Other DED diagnosis using PAOSID
    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).
  • Other DED diagnosis using slit lamp
    A non-invasive diagnostic approach using the slit lamp to capture anterior segment images and videos for the assessment of dry eye disease (DED).

Primary outcome measures

  • Agreement between PAOSID-based and slit-lamp-based DED diagnosis [Time frame: At baseline (Day 0)]

Eligibility criteria

Inclusion criteria

  • 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.
  • Participants, or their companions or caregivers, who are willing and able to use the study smartphone to capture relevant eye images and videos.
  • Aged 18 years or older.
  • Provide informed consent.

Exclusion criteria

  • 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).
  • Patients currently wearing scleral lenses or bandage contact lenses.
  • Unable to cooperate with the PAOSID, such as due to a serious mental illness or brain damage causing loss of limb control.
  • Significant changes in the ocular images since diagnosis due to factors such as postdiagnostic treatment.

Eye selection criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

China · 1 center
  • The Eye Hospital, Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT06984549 · ChiCTR2500097802 · 263551

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗