Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07554911

Detection and Optimization of Treatment of Severe Cases of Dry Eye Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore Eye Research Institute

Singapore, 169856

Location status: Recruiting

Location contact

Sharon Yeo, BSc

CONTACT

[email protected]

65767200

About this study

Investigators have shown that a single corneal picture after dye staining can detect DED that are ideally managed at tertiary care because these require prescription eyedrops. The main type of DED patients that respond to cyclosporine eyedrops are those with severe cornea staining. In collaboration with data scientists from ASTAR, the preliminary data involving more than 1000 images from China and Singapore show that this artificial intelligence-based screening is sensitive and specific.

By reducing unnecessary referrals to hospitals, investigators will make healthcare more sustainable and affordable. Previously, patients in the community are evaluated purely based on subjective symptoms. investigators not only standardize this with a validated and short DEQ5 questionnaire, but evaluate the accuracy of screening is improved by using the AI algorithms on the corneal image, a prototype, in addition to the DEQ5, and in place of the DEQ5.

Aim: 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.

Rationale: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21 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

Exclusion criteria

  • All subjects meeting any of the exclusion criteria at baseline will be excluded from participation and then list the criterion.
  • Any other specified reason as determined by clinical investigator

Treatment and study plan

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.

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Yeo, BSc

CONTACT

[email protected]

65767200

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.