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

ConditionDry Eye
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Healthy adults aged 18 to 60;

Disqualifiers

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;

Trial population

This study intends to include patients with dry eye and healthy controls as the research subjects.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

75 Participants
are grouped into 2 trial groups
Group A: dry eye group
Group B: control group

Trial outcomes

Primary outcomes

1

in vivo confocal microscopy examination

Images of the central corneal area and the inferior thread area of the patients were collected using in vivo confocal microscopy. During the examination, the patient's lower jaw is placed on the bracket, the forehead is tightly against the frontal support, and the patient is fixated on the target. A corneal contact probe is used. After applying Carbomer gel, it touches the corneal surface and scans layer by layer to obtain images of each layer of the cornea. The clear images of the linear nerves in the central area of the cornea and the vortex-like nerves in the lower vortex-like area were mainly collected for the subsequent intelligent analysis system to extract the morphological parameters of the corneal nerves and the parameters of inflammatory cells.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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