Evaluation of a portable device for diagnosing dry eye disease
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 is testing a new portable device to see if it can accurately diagnose dry eye disease compared to traditional eye exams.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Eye Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT06984549 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic accuracy and grading consistency of a portable automatic ocular surface imaging device (PAOSID) for assessing dry eye disease (DED). Participants, including those diagnosed with DED and healthy volunteers, will undergo conventional clinical imaging and then use the PAOSID device to capture ocular surface images and videos independently. The study aims to compare the results from the PAOSID with traditional slit-lamp examinations to determine its effectiveness in diagnosing DED. The clinical grading of DED severity will follow established criteria, ensuring a comprehensive assessment of the condition.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with a diagnosis of dry eye disease or healthy individuals with no ocular conditions.
Not a fit: Patients with other ocular surface disorders or significant vision impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and efficient method for diagnosing dry eye disease.
How similar studies have performed: Other studies have shown promise in using portable imaging devices for ocular assessments, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wenzhou, Zhejiang
- The Eye Hospital, Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ruobing Xia
- Email: xiaruobing2000@163.com
- Phone: +86 13634238380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.