Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

7. juli 2026 opdateret af: Jian Xiong, Second Affiliated Hospital of Nanchang University

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
      • Jiangxi, Kina
        • Rekruttering
        • The Second Affiliated Hospital of Nanchang University, Nanchang, JiangXi 330000
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

  1. Age 18 to 60 years, of either sex;
  2. 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;
  3. Best-corrected visual acuity of 20/25 or better in each eye;
  4. Clear cornea, no keratoconus, corneal scarring, or other pathologies; clear lens;
  5. Intraocular pressure of 21 mmHg or less, with no history of glaucoma;
  6. No history of ocular surgery, especially corneal refractive surgery or cataract surgery;
  7. Time interval between non-cycloplegic refraction and cycloplegic refraction of 7 days or less, with complete data.

Exclusion Criteria:

  1. Incomplete clinical data to support the diagnosis;
  2. Ocular conditions such as subclinical keratoconus, keratoconus, or moderate-to-severe corneal haze or leukoma;
  3. Allergy or contraindication to cycloplegic agents;
  4. Refusal to participate in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk 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.
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.
Diagnostisk 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy of predicted cycloplegic spherical equivalent
Tidsramme: 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.
Day 0

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic performance for identifying patients requiring cycloplegic refraction
Tidsramme: Day 0
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.
Day 0
Agreement between predicted and measured cycloplegic refraction
Tidsramme: Day 0
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.
Day 0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital of Nanchang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. oktober 2023

Primær færdiggørelse (Anslået)

25. november 2026

Studieafslutning (Anslået)

25. november 2026

Datoer for studieregistrering

Først indsendt

21. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • [2026] NO.(123)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brydningsfejl

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Moldova

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner