Dry Eye Disease (DED)NCT06984549
Telemedicine Evaluation of Dry Eye Disease Using a Portable Automatic Ocular Surface Imaging Device (PAOSID)
An observational study of Dry Eye Disease (DED), run by Chen Wei at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- DED diagnosis using PAOSID and DED diagnosis using slit lamp
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Ruobing Xia, +86 13634238380, xiaruobing2000@163.com
About this study
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
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.
Read the detailed description
Multicenter, Cross-sectional
- Conditions
- Dry Eye Disease (DED)
- Being tested
- DED diagnosis using PAOSID, DED diagnosis using slit lamp
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DED diagnosis using PAOSIDOther
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 lampOther
A non-invasive diagnostic approach using the slit lamp to capture anterior segment images and videos for the assessment of dry eye disease (DED).
| Study group | Role | What they receive |
|---|---|---|
| DED group | Not described Receives: Other: DED diagnosis using PAOSID; Other: DED diagnosis using slit lamp | |
| healthy control | Not described Receives: Other: DED diagnosis using PAOSID; Other: DED diagnosis using slit lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between PAOSID-based and slit-lamp-based DED diagnosis
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Mar 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore National Eye Centre, University of Sydney
- Responsible party
- Sponsor-investigator, Chen Wei, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984549
- Sponsor's protocol ID
- ChiCTR2500097802
- Other IDs
- 263551
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06984549
- Acronym / sponsor ID
- ChiCTR2500097802
- Conditions
- Dry Eye Disease (DED)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chen WeiUniversity, hospital or other
- Collaborators
- Singapore National Eye Centre, University of Sydney
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DED diagnosis using PAOSIDA 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 group, healthy control |
| DED diagnosis using slit lampA non-invasive diagnostic approach using the slit lamp to capture anterior segment images and videos for the assessment of dry eye disease (DED). | Other | DED group, healthy control |
Primary outcome
Agreement between PAOSID-based and slit-lamp-based DED diagnosis
Time frame: At baseline (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease (DED), run by Chen Wei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruobing Xia (+86 13634238380, xiaruobing2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between PAOSID-based and slit-lamp-based DED diagnosis (time frame: At baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.