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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Dry Eye Disease (DED)
• Intervention / Treatment: Diagnostic test: Dr Eye

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louis Tong, PhD; Phone Number: 65767200; Email: louis.tong.h.t@singhealth.com.sg
• Study Contact Backup: Name: Sharon Yeo, BSc; Phone Number: 65767200; Email: sharon.yeo.w.j@seri.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient diagnose with Dry Eye Disease	Diagnostic test: 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.
Other: Healthy subject	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective is to study the diagnostic accuracy of remote Dry Eye Disease (DED) diagnosis using a portable automatic ocular surface imaging device (PAOSID), as compared with standard clinical DED diagnosis.	From enrollment to end of visit 1, estimated 1 hour (One Time Visit)

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary objectives: diagnostic consistency of remote Dry Eye Disease (DED) diagnosis using a portable automatic ocular surface imaging device (PAOSID), as compared with standard clinical DED diagnosis.	From enrollment to end of visit 1, estimated 1 hour (One Time Visit)

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Collaborators: The Eye Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Louis Tong, PhD, Singapore Eye Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): January 9, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PAOSID; Dr EYE
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 2025-0263 (Other Identifier: SingHealth CIRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No