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

NCT06984549 | Recruiting

• 2 other identifiers: ChiCTR2500097802263551
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• Agreement between PAOSID-based and slit-lamp-based DED diagnosis

  At baseline (Day 0)

Study Arms (2)

DED group

Other: DED diagnosis using PAOSID; Other: DED diagnosis using slit lamp

healthy control

Other: DED diagnosis using PAOSID; Other: DED diagnosis using slit lamp

Interventions

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 group; healthy control

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).

DED group; healthy control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chen Wei: lead
• Singapore National Eye Centre: collaborator
• University of Sydney: collaborator

Study Sites (1)

The Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Ruobing Xia

CONTACT

+86 13634238380; xiaruobing2000@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 22, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)