Clinical trial NCT06984549: Telemedicine Evaluation of Dry Eye Disease Using a Portable Automatic Ocular Surface Imaging Device (PAOSID)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Disease (DED)
Lead sponsor: The Eye Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Singapore National Eye Centre
name: University of Sydney
First posted: 2025-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: Multicenter, Cross-sectional

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participants, or their companions or caregivers, who are willing and able to use the study smartphone to capture relevant eye images and videos.
3. Aged 18 years or older.
4. Provide informed consent.

Exclusion Criteria:

1. 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).
2. Patients currently wearing scleral lenses or bandage contact lenses.
3. Unable to cooperate with the PAOSID, such as due to a serious mental illness or brain damage causing loss of limb control.
4. Significant changes in the ocular images since diagnosis due to factors such as postdiagnostic treatment.

Eye selection criteria

Primary outcomes:
measure: Agreement between PAOSID-based and slit-lamp-based DED diagnosis
timeFrame: At baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Eye Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
References: