Using AI to predict complications in SMILE eye surgery

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

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
• Enrollment: 1250 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT06204926 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility 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 this trial is running

Nanchang, Jiangxi

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

Study contacts

• Study coordinator: Jian Xiong, docter

Conditions Deep Convolutional Neural Network; Small-incision Lenticule Extraction Surgery; Intraoperative Complications; Postoperative Outcomes; femtosecond laser small-incision lenticule extraction