Development and Evaluation of an Intelligent Diagnosis System for Dry Eye Disease Based on Confocal Microscopy

Обзор

Dry eye disease is a major ophthalmic health issue that severely affects the visual function and quality of life of the national population. Its core pathological mechanism involves a vicious cycle of ocular surface inflammation and neural abnormalities; however, clinical practice still lacks an objective and quantitative gold standard for diagnosis. Although in vivo confocal microscopy (IVCM) enables cellular-level, in vivo observation of the ocular surface, image analysis remains heavily dependent on manual interpretation, highlighting an urgent need for an intelligent quantitative framework.This project aims to construct a high-quality, standardized ocular surface imaging database and develop a high-precision deep learning algorithm to achieve accurate segmentation and quantification of corneal nerves (including both whorl-like and linear patterns) and inflammatory cells, and to validate their associations with clinical indicators of dry eye disease. The ultimate goal is to develop and evaluate an IVCM-based multimodal intelligent diagnostic system for dry eye, transforming IVCM from an observational tool into an intelligent decision-support system, with real-world performance validated through an independent prospective cohort.This project is expected to establish a multimodal AI diagnostic model for dry eye, create a standardized computational framework for imaging biomarkers, and enable a paradigm shift from qualitative description to quantitative diagnosis. The findings will provide reliable decision-making support for precision subtyping and personalized treatment of dry eye disease, advancing ophthalmic practice toward a data-driven, intelligent paradigm.

Первичные конечные точки

• in vivo confocal microscopy examination [Срок оценки: Baseline]

Критерии участия

Критерии включения

Normal group:

• Healthy adults aged 18 to 60;
• OSDI score of ocular surface disease Index <13 points;
• Good tear film stability (tear film break-up time TBUT≥10 seconds) and negative corneal fluorescein staining;

Dry eye Group:

• Healthy adults aged 18 to 60;
• Tear film break-up time ≤5 seconds or SchirmerⅠ≤5mm/5min without surface anesthesia, with one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or vision fluctuation in the eyes;
• 5 <Tear film break-up time ≤10 seconds or 5mm/5 min/less under no surface anesthesia; When SchirmerⅠ is ≤10 mm/5min, there is one of the subjective symptoms in the eyes, such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and vision fluctuation. At the same time, the fluorescein staining of the cornea and conjunctiva is positive.

Критерии исключения

• Combined with systemic diseases or neurological diseases that may affect corneal nerve function;
• Having used any local anti-inflammatory drugs for the eyes within 2 weeks before enrollment or having a history of wearing contact lenses within 3 months;
• Other eye diseases besides dry eye and history of eye surgery;

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

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07614347 · TREC2026-KY070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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