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临床试验/NCT07690813
NCT07690813招募中不适用

Efficacy of Machine Learning Models for Predicting Cycloplegic Refractive Error Based on Non-Cycloplegic Parameters in Adults With Myopia

Second Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2023年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
1
主要终点
Accuracy of predicted cycloplegic spherical equivalent

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 47 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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;
  • •Intraocular pressure of 21 mmHg or less, with no history of glaucoma;
  • •No history of ocular surgery, especially corneal refractive surgery or cataract surgery;
  • •Time interval between non-cycloplegic refraction and cycloplegic refraction of 7 days or less, with complete data.

排除标准

  • •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.

研究组 & 干预措施

Group with spherical equivalent change <0.50 diopters after 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.

干预措施: Machine learning model for predicting cycloplegic refraction (Diagnostic Test)

Group with spherical equivalent change ≥0.50 diopters after cycloplegic refraction

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.

干预措施: Machine learning model for predicting cycloplegic refraction (Diagnostic Test)

结局指标

主要结局

Accuracy of predicted cycloplegic spherical equivalent

时间窗: Day 0

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.

次要结局

  • Diagnostic performance for identifying patients requiring cycloplegic refraction(Day 0)
  • Agreement between predicted and measured cycloplegic refraction(Day 0)

研究者

发起方
Second Affiliated Hospital of Nanchang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian Xiong

Associate research fellow; Attending physician

Second Affiliated Hospital of Nanchang University

研究点 (1)

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