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NCT Number: NCT07478419

Machine Learning Prediction of 1-Year Refractive Error After SMILE

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Myopic Astigmatism Refractive Error - Myopia Axial Refractive Errors

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mean Absolute Error of Predicted 1-Year Postoperative Spherical Equivalent Prediction Error

    Time frame: 1 year after SMILE

    Model performance for prediction of 1-year postoperative spherical equivalent prediction error, assessed in diopters.

Secondary outcomes

  1. Mean Absolute Error of Predicted 1-Year Postoperative J0 Prediction Error

    Time frame: 1 year after SMILE

    Model performance for prediction of the cardinal astigmatic vector component (J0), assessed in diopters.

  2. Mean Absolute Error of Predicted 1-Year Postoperative J45 Prediction Error

    Time frame: 1 year after SMILE

    Mean Absolute Error of Predicted 1-Year Postoperative J45 Prediction Error

Sponsors and collaborators

Lead sponsor

Tongji University

Other

Registry information

Official study title

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

Acronym: SMILE

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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