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AI eye doctor: algorithm aims to predict SMILE surgery risks

NCT ID NCT06204926

Diagnosis Sponsor: Second Affiliated Hospital of Nanchang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an artificial intelligence (AI) algorithm that analyzes videos from SMILE eye surgery to predict complications like cloudy bubbles or suction loss during the procedure, as well as outcomes like vision correction and corneal thickness afterward. Researchers will enroll 1,250 people with nearsightedness to see how accurate the AI is. If it works, this tool could help surgeons make safer decisions during laser eye surgery.

What this could mean

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

Active substance
AI diagnostic algorithm
What this could lead to
If successful, this AI tool could help surgeons predict and avoid complications during SMILE eye surgery, leading to safer procedures and better vision outcomes.
What could go wrong
This is an early-stage diagnostic study, not a treatment. The AI may not be accurate enough in real-world settings, and results may not apply to all patients or surgeries.

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 1,250 people

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

Started

Jun 2021

Expected to finish

Dec 2027

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

Patients from clinics in different eye centers across China. Each subject must with complete surgical video recording and medical records.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * A condition in which the spherical equivalent refractive error of an eye is ≤-0.50 D when ocular accommodation is relaxed; * Age ≥18 years; * Spherical equivalent (SE) ≥-10.0D; * Corrected distance visual acuity (CDVA) ≥16/20; * Stable myopia for at least 2 years; * No contact lenses wearing for at least 2 weeks. Exclusion Criteria: * The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury; * A history of eye surgery; * The presence or history of systemic diseases.

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Conditions

The condition(s) this trial relates to.

Intraoperative Complications Smiling

As listed by the trial registrant

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

Deep convolutional neural network Intraoperative complications Postoperative outcomes Small-incision lenticule extraction (smile) surgery

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330000, China

More trials for these conditions

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