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

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-09

Study Completion Date

2026-12-31

Brief Summary

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Dry eye disease (DED) is a common eye condition that is becoming more widespread. Detecting it early, keeping track of its progression, and following up regularly can help protect vision and prevent serious complications. However, due to a shortage of ophthalmologists, limited access to eye care services, and disparities in care quality, many patients receive infrequent or insufficient clinical consultations.

To address these needs, a portable automatic ocular surface imaging device (PAOSID) that attaches to a mobile phone has been developed. This device uses three types of light including white, infrared, and cobalt blue light to capture clear images and videos of the eye's surface.

It also has a smart system that automatically takes high-quality images, allowing patients to use it at home independently. This device may help detect early signs of DED and monitor eye health more easily.

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Detailed Description

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Conditions

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Dry Eye Dry Eye Disease (DED)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patient diagnose with Dry Eye Disease

Group Type OTHER

Dr Eye

Intervention Type DIAGNOSTIC_TEST

Portable automatic ocular surface imaging device (PAOSID) that attaches to a mobile phone has been developed. This device uses three types of light including white, infrared, and cobalt blue light to capture clear images and videos of the eye's surface.

It also has a smart system that automatically takes high-quality images, allowing patients to use it at home independently. This device may help detect early signs of DED and monitor eye health more easily.

Healthy subject

Group Type OTHER

Dr Eye

Intervention Type DIAGNOSTIC_TEST

Portable automatic ocular surface imaging device (PAOSID) that attaches to a mobile phone has been developed. This device uses three types of light including white, infrared, and cobalt blue light to capture clear images and videos of the eye's surface.

It also has a smart system that automatically takes high-quality images, allowing patients to use it at home independently. This device may help detect early signs of DED and monitor eye health more easily.

Interventions

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Dr Eye

Portable automatic ocular surface imaging device (PAOSID) that attaches to a mobile phone has been developed. This device uses three types of light including white, infrared, and cobalt blue light to capture clear images and videos of the eye's surface.

It also has a smart system that automatically takes high-quality images, allowing patients to use it at home independently. This device may help detect early signs of DED and monitor eye health more easily.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Participants diagnosed as DED by experienced ophthalmologists, based on the TFOS DEWS II (The Tear Film and Ocular Surface Society Dry Eye Workshop II) guidelines,(19) as well as 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 21 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. Significant changes in the ocular images since diagnosis due to factors such as postdiagnostic treatment;
4. Unable to cooperate with the PAOSID, such as due to a serious mental illness or brain damage causing loss of limb control;
5. Eyes with previous or active corneal diseases such as infectious keratitis, corneal opacity or dystrophy;
6. Eyes with active inflammation or infection.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes