Evaluation of a portable device for diagnosing dry eye disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Eye Hospital, Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ruobing Xia
• Email: xiaruobing2000@163.com
• Phone: +86 13634238380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.