An observational study in Refractive Errors, Cycloplegic Refraction and Accommodation, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 47 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Second Affiliated Hospital of Nanchang University · Observational
This study presents a machine learning model that predicts cycloplegic refraction in adults with myopia using standard non-cycloplegic eye measurements, aiming to reduce the need for cycloplegic drops while still identifying patients who require them.
Myopia is a highly prevalent, irreversible refractive disorder with substantial impact on quality of life. Cycloplegic refraction is the gold standard for assessing refractive error in adults considering optical or surgical correction, but it is time-consuming, slow to recover from, and frequently associated with ocular discomfort. Non-cycloplegic refraction is therefore used routinely in clinical practice, despite known differences from cycloplegic values in a subset of adult myopes.
Critically, this discrepancy varies substantially between individuals and cannot be anticipated from non-cycloplegic measurements alone. Clinicians have no reliable way to identify, prior to dilation, which patients are likely to be overcorrected if cycloplegia is omitted, potentially leading to overcorrected prescriptions, asthenopia, and myopic progression.
Machine learning approaches that capture non-linear relationships between clinical predictors and refractive outcomes have shown promise in children, but comparable models for adults remain largely unexplored, and most rely on axial length, which is unavailable in routine optometric settings. Refractive surgery centers offer a uniquely suitable data source, as every candidate undergoes standardized paired non-cycloplegic and cycloplegic refraction with detailed anterior segment biometry during routine preoperative evaluation. This study leverages such data to develop and validate models estimating cycloplegic refractive error from non-cycloplegic parameters, providing a decision-support tool that reduces unnecessary cycloplegia while flagging patients for whom dilated refraction remains indicated.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 150 across 108 observational studies indexed under Refractive Errors.
Browse Refractive Errors studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 85 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Each subject underwent a comprehensive preoperative examination, including cycloplegic and non-cycloplegic refractions, Pentacam, etc.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Adult myopes with a non-cycloplegic versus cycloplegic spherical equivalent difference of ≥0.50 diopters, for whom cycloplegic refraction is clinically warranted, received routine cycloplegic refraction with tropicamide; no other intervention was given.
Diagnostic Test: Machine learning model for predicting cycloplegic refraction
Adult myopes with an absolute difference of less than 0.50 diopters between non-cycloplegic and cycloplegic spherical equivalent, for whom non-cycloplegic refraction is considered sufficient, received routine cycloplegic refraction with tropicamide; no additional intervention was applied.
Diagnostic Test: Machine learning model for predicting cycloplegic refraction
The machine learning model was applied to each participant's non-cycloplegic parameters to predict cycloplegic spherical equivalent.
Accuracy of predicted cycloplegic spherical equivalent
Accuracy of the machine learning model in predicting cycloplegic spherical equivalent in the validation dataset, evaluated by mean absolute error, root mean square error, and coefficient of determination, expressed for spherical equivalent in diopters.
Time frame: Day 0
Diagnostic performance for identifying patients requiring cycloplegic refraction
Area under the receiver operating characteristic curve, sensitivity, and specificity of the model for classifying patients with an absolute difference of 0.50 diopters or more between non-cycloplegic and cycloplegic spherical equivalent in the validation dataset.
Time frame: Day 0
Agreement between predicted and measured cycloplegic refraction
Agreement between predicted and measured cycloplegic spherical equivalent assessed by Bland-Altman analysis with mean bias and 95% limits of agreement, and by the intraclass correlation coefficient in the validation dataset.
Time frame: Day 0
Plan to share: No
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Started Oct 2023 (actual). Primary completion is estimated for Nov 2026, 37 months after the start.
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Second Affiliated Hospital of Nanchang University