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

Singapore National Eye Centre

Status: Not yet enrolling

Conditions: Dry Eye; Dry Eye Disease (DED)

Treatments: Diagnostic Test: Dr Eye

Study type: Interventional

Funder types: Other

Identifiers

NCT07341724

2025-0263 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Patient diagnose with Dry Eye Disease

Other group

Treatment:

Diagnostic Test: Dr Eye

Healthy subject

Other group

Treatment:

Diagnostic Test: Dr Eye