ML Models Predicting Cycloplegic Refractive Error Based on Non-Cycloplegic Parameters in Myopic Adults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-47
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 60 years, of either sex;

Spherical equivalent between -0.50 diopters and -10.00 diopters, with myopia in one or both eyes, and with cylinder of 4.00 diopters or less;

Best-corrected visual acuity of 20/25 or better in each eye;

Clear cornea, no keratoconus, corneal scarring, or other pathologies; clear lens;

Disqualifiers

Incomplete clinical data to support the diagnosis;

Ocular conditions such as subclinical keratoconus, keratoconus, or moderate-to-severe corneal haze or leukoma;

Allergy or contraindication to cycloplegic agents;

Refusal to participate in the study.

Trial population

Each subject underwent a comprehensive preoperative examination, including cycloplegic and non-cycloplegic refractions, Pentacam, etc.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Machine learning model for predicting cycloplegic refraction

    Diagnostic test

    The machine learning model was applied to each participant's non-cycloplegic parameters to predict cycloplegic spherical equivalent.

Treatment groups

2,500 Participants
are divided into 2 treatment groups
Group A: Group with spherical equivalent change ≥0.50 diopters after cycloplegic refraction1 intervention
Group B: Group with spherical equivalent change <0.50 diopters after cycloplegic refraction1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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