Telemedicine Evaluation of Dry Eye Disease Using a Portable Automatic Ocular Surface Imaging Device (PAOSID)
NCT ID: NCT06984549
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2025-03-01
2025-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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DED group
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).
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).
healthy control
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).
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Singapore National Eye Centre
OTHER_GOV
University of Sydney
OTHER
Chen Wei
OTHER
Responsible Party
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Chen Wei
Sponsor-Investigator
Locations
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The Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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263551
Identifier Type: REGISTRY
Identifier Source: secondary_id
ChiCTR2500097802
Identifier Type: -
Identifier Source: org_study_id
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