Machine Learning Prediction of 1-Year Refractive Error After SMILE

Development and Internal Validation of a Multi-output Machine Learning Model for Predicting 1-Year Postoperative Refractive Prediction Error After Small Incision Lenticule Extraction and Comparative Virtual Planning Analysis Against ZEISS 4.0

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07478419

Acronym

SMILE

Enrollment

1100

Registered

2026-03-17

Start date

2018-09-01

Completion date

2026-01-31

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Myopic Astigmatism, Refractive Error - Myopia Axial

Keywords

Refractive Error, Small Incision Lenticule Extraction, Nomogram, Refractive Surgery

Brief summary

This retrospective single-center observational study is designed to develop and internally validate a multi-output machine learning model for predicting 1-year postoperative refractive prediction error after small incision lenticule extraction (SMILE). The primary modeling target is 1-year spherical equivalent prediction error. Secondary targets include J0 prediction error, J45 prediction error, and postoperative uncorrected distance visual acuity in logarithm of the minimum angle of resolution. A secondary objective is to use the prediction framework to derive individualized nomogram recommendations and to compare these recommendations with ZEISS 4.0 planning in a virtual treatment-planning analysis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Eyes that underwent SMILE for correction of myopia or myopic astigmatism * Availability of preoperative examination data and surgical planning data * Availability of postoperative follow-up data at approximately 1 year * Age ≥ 18 years

Exclusion criteria

* Previous ocular surgery in the study eye * Ocular comorbidity likely to affect refractive or visual outcome * Intraoperative or postoperative complications that precluded standard outcome assessment * Missing key variables required for analysis

Design outcomes

Primary

Measure	Time frame	Description
Mean Absolute Error of Predicted 1-Year Postoperative Spherical Equivalent Prediction Error	1 year after SMILE	Model performance for prediction of 1-year postoperative spherical equivalent prediction error, assessed in diopters.

Secondary

Measure	Time frame	Description
Mean Absolute Error of Predicted 1-Year Postoperative J0 Prediction Error	1 year after SMILE	Model performance for prediction of the cardinal astigmatic vector component (J0), assessed in diopters.
Mean Absolute Error of Predicted 1-Year Postoperative J45 Prediction Error	1 year after SMILE	Mean Absolute Error of Predicted 1-Year Postoperative J45 Prediction Error

Countries

China

Outcome results