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NCT Number: NCT06984549

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Ruobing Xia

CONTACT

[email protected]

+86 13634238380

About this study

Multicenter, Cross-sectional

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DED diagnosis using PAOSID

Other

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).

DED diagnosis using slit lamp

Other

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 outcomes

  1. Agreement between PAOSID-based and slit-lamp-based DED diagnosis

    Time frame: At baseline (Day 0)

Study contacts

Contact information is provided by the study sponsor or research team.

Ruobing Xia

CONTACT

[email protected]

+86 13634238380

Sponsors and collaborators

Lead sponsor

Chen Wei

Other

Collaborators

  • Singapore National Eye Centre
  • University of Sydney

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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