NCT07554911

Brief Summary

The bulk of dry eye patients are found in the community. The lack of satisfactory protocols and confidence is a significant deterrent for practitioners to manage such patients, which may result in inaccurate referrals, and unhappy patients. Problems are compounded by comorbidities of dry eye, even if these are not diagnosed formally. Aligning with the healthcare strategy to move beyond healthcare to health, and beyond hospital care to community care, investigators propose that the confidence of primary carers be increased by using an image-based screening system. This study aim to determine the efficacy of this screening AI algorithm, a prototype, in addition to or instead of screening of dry eye using a simple DEQ-5 symptom questionnaire.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Oct 2023Jul 2028

Study Start

First participant enrolled

October 18, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

April 21, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

dry eye

Outcome Measures

Primary Outcomes (1)

  • Determine the efficacy of this screening AI algorithm, a prototype, in addition to or instead of screening of dry eye using a simple DEQ-5 symptom questionnaire.

    DEQ-5 is aimed to detect dry eye cases, but not necessarily dry eye requiring specialist care. The AI algorithm picks up cases with central cornea staining, which can then be referred for specialist care. Non-referred cases can be managed with eyelid warming, artificial tears and advice, with the aim of rescreening at a later time.

    3 years

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

dry eye patients

You may qualify if:

  • years old and above
  • Participants must be previously diagnosed with dry eye in the dry eye clinic (previous referred and had various forms of treatment such as artificial tears or prescription eyedrops)
  • Willing to perform all eye examinations and questionnaires in this study
  • Ability to provide informed consent

You may not qualify if:

  • Any other specified reason as determined by clinical investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Louis Tong

    Singapore Eye Research Institute (SERI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start

October 18, 2023

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations