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New AI reads eye scans to diagnose dry eye instantly

NCT ID NCT07614347

Diagnosis Sponsor: Capital Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to create an artificial intelligence system that can automatically analyze confocal microscopy images of the cornea to diagnose dry eye disease. Researchers will collect eye scans from 75 adults (healthy and with dry eye) to train and test the AI. The goal is to replace slow, manual image analysis with a fast, objective, and quantitative diagnostic tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a fast, objective, and automated way to diagnose dry eye disease, replacing subjective manual methods.
What could go wrong
This is an early-stage, small study (75 participants) focused on developing and testing the AI system, not a treatment trial. The AI may not perform well in real-world settings or on diverse populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 60 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Normal group: 1. Healthy adults aged 18 to 60; 2. OSDI score of ocular surface disease Index \<13 points; 3. Good tear film stability (tear film break-up time TBUT≥10 seconds) and negative corneal fluorescein staining; Dry eye Group: 1. Healthy adults aged 18 to 60; 2. 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; 3. 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. Exclusion Criteria: 1. Combined with systemic diseases or neurological diseases that may affect corneal nerve function; 2. 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; 3. Other eye diseases besides dry eye and history of eye surgery;

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.