NCT07690813

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Oct 2023Nov 2026

Study Start

First participant enrolled

October 3, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2026

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

3.1 years

First QC Date

June 21, 2026

Last Update Submit

July 7, 2026

Conditions

Cycloplegic RefractionAccommodationRefractive Errors

Keywords

AccommodationCycloplegic refractionRefractive errors

Outcome Measures

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.

    Day 0

Secondary Outcomes (2)

  • Diagnostic performance for identifying patients requiring cycloplegic refraction

    Day 0

  • Agreement between predicted and measured cycloplegic refraction

    Day 0

Study Arms (2)

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.

Diagnostic Test: Machine learning model for predicting cycloplegic refraction

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.

Diagnostic Test: Machine learning model for predicting cycloplegic refraction

Interventions

Machine learning model for predicting cycloplegic refractionDIAGNOSTIC_TEST

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

Group with spherical equivalent change <0.50 diopters after cycloplegic refractionGroup with spherical equivalent change ≥0.50 diopters after cycloplegic refraction

Eligibility Criteria

Age18 Years - 47 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University, Nanchang, JiangXi 330000

Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

jian xiong

CONTACT

18170906556894040417@qq.com

Fu Gui

CONTACT

1387910191564436578@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate research fellow; Attending physician

Study Record Dates

First Submitted

June 21, 2026

First Posted

July 8, 2026

Study Start

October 3, 2023

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

November 25, 2026

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)