NCT06984549 Telemedicine Evaluation of Dry Eye Disease Using a Portable Automatic Ocular Surface Imaging Device (PAOSID)
| NCT ID | NCT06984549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chen Wei |
| Condition | Dry Eye Disease (DED) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-03-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06984549 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease (DED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06984549 currently recruiting?
Yes, NCT06984549 is actively recruiting participants. Contact the research team at xiaruobing2000@163.com for enrollment information.
Where is the NCT06984549 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT06984549 clinical trial?
NCT06984549 is sponsored by Chen Wei. The trial plans to enroll 150 participants.