Clinical trial Recruiting at 1 site Observational Ages 18 to 45

Using AI to predict complications in SMILE eye surgery

Official title: Diagnostic Efficacy of Convolutional Neural Network Based Algorithm in Predicting Intraoperative Complications and Postoperative Outcomes in Small Incision Lenticule Extraction

Run by Second Affiliated Hospital of Nanchang University · NCT06204926 · Data updated 2026-11-12

This study is testing if an AI tool can help predict problems during and after SMILE eye surgery to improve outcomes for patients.

Quick facts

Study typeObservational
Ages18 Years to 45 Years
SexAll
Enrollment1250 (estimated)
SponsorSecond Affiliated Hospital of Nanchang University
Academic / other
Locations1 site (Nanchang, Jiangxi)
StatusRecruiting
StartedJune 15, 2021
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedApril 24, 2026
Trial IDNCT06204926 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with stable myopia and specific refractive error criteria.

Probably not a fit

Patients with a history of eye surgery or other significant eye conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the effectiveness of a deep convolutional neural network (CNN) in predicting intraoperative complications and postoperative outcomes during Small Incision Lenticule Extraction (SMILE) surgery. By analyzing scan images and patient data, the AI algorithm aims to enhance the accuracy of predicting complications that can arise due to individual corneal characteristics. The study is multi-centered and seeks to assess the real-world utility of this AI diagnostic tool in improving surgical outcomes for patients undergoing SMILE procedures.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction of complications during SMILE surgery, enhancing patient safety and recovery.

How similar studies have gone: Previous studies have shown that AI can achieve accuracy comparable to human physicians in medical imaging interpretation, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.