Machine Learning Prediction of 1-Year Refractive Error After SMILE

NCT07478419 | Completed

• 2 other identifiers: 2026MLSHDC12025144
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Myopic Astigmatism; Refractive Error - Myopia Axial

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  1 year after SMILE

Secondary Outcomes (2)

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

  1 year after SMILE

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

  1 year after SMILE

Study Arms (2)

Training Cohort

Eyes included in the prespecified training dataset for development of the multi-output machine learning model.

Test Cohort

Eyes included in the prespecified independent test dataset for internal validation of the multi-output machine learning model.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People with moderate myopia who have undergone SMILE surgeries

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Myopia; Astigmatism; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: September 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)