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 type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 1250 (estimated) |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Status | Recruiting |
| Started | June 15, 2021 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT06204926 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
- Study coordinator: Jian Xiong, docter
- Email: 894040417@qq.com
- Phone: 18170906556
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.