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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• 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. [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Сингапур · 1 центр

• Singapore Eye Research Institute — Singapore

Идентификаторы

NCT: NCT07554911 · 2023-2479 · MOH-001363-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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