NCT07341724

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

December 21, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 21, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

PAOSIDDr EYE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (2)

Patient diagnose with Dry Eye Disease

OTHER
Diagnostic Test: Dr Eye

Healthy subject

OTHER
Diagnostic Test: Dr Eye

Interventions

Dr EyeDIAGNOSTIC_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 subjectPatient diagnose with Dry Eye Disease

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Participants, or their companions or caregivers, who are willing and able to use the study smartphone to capture relevant eye images and videos;
  • Aged 21 years or older;
  • Provide informed consent.

You may not qualify if:

  • 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).
  • Patients currently wearing scleral lenses or bandage contact lenses.
  • Significant changes in the ocular images since diagnosis due to factors such as postdiagnostic treatment;
  • Unable to cooperate with the PAOSID, such as due to a serious mental illness or brain damage causing loss of limb control;
  • Eyes with previous or active corneal diseases such as infectious keratitis, corneal opacity or dystrophy;
  • Eyes with active inflammation or infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Louis Tong, PhD

    Singapore Eye Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist, Senior Consultant

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 14, 2026

Study Start

January 9, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 14, 2026

Record last verified: 2025-12