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Development and Validation of an IOL-Master Biometry-Based Adaptive Prediction Model for Refractive Status in Children and Adolescents: A Retrospective Longitudinal Study

Development and Validation of an IOL-Master Biometry-Based Adaptive Prediction Model for Refractive Status in Children and Adolescents: A Retrospective Longitudinal Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125047
Enrollment
Unknown
Registered
2026-05-20
Start date
2026-05-21
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive error

Interventions

Training set:None
Validation set:None

Sponsors

The Eye Hospital of Wenzhou Medical University, Hangzhou Branch
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 3 and 18 years (inclusive); 2. Patients who had at least one outpatient visit with a complete set of the following data: Non-cycloplegic or cycloplegic subjective refraction/retinoscopy; IOL-Master biometry data; Spectacle dispensing records within 2 weeks; 3. Patients with at least two visits containing complete subjective refraction (or retinoscopy) and axial length data, with a follow-up interval of >= 6 months between visits.(for the retrospective cohort).

Exclusion criteria

Exclusion criteria: 1.Presence of organic eye diseases: Including but not limited to congenital cataract, glaucoma, keratoconus, retinopathy, nystagmus, and retinal detachment. 2.History of ocular surgery: Including but not limited to strabismus surgery, congenital cataract surgery. 3.Interference from medications or interventions: History of wearing orthokeratology (Ortho-K) lenses (due to induced changes in corneal morphology or axial length). History of using other myopia control interventions (e.g., defocus spectacles, defocus soft contact lenses, low-concentration atropine, etc.). 4.Unreliable biometric data: Low signal-to-noise ratio (SNR) or unreliable data quality in IOL-Master measurements (e.g., standard deviation [SD] of axial length measurement > 0.05 mm). 5.Systemic diseases affecting ocular development (Such as Marfan syndrome, albinism, etc).

Design outcomes

Primary

MeasureTime frame
Prediction accuracy;Diagnostic efficiency;

Secondary

MeasureTime frame
Prediction success rate;The prediction performance of astigmatism vectors;The operational efficiency of digital tools;

Countries

China

Contacts

Public ContactHu Jiong

The Eye Hospital of Wenzhou Medical University, Hangzhou Branch

hjjjohn@163.com+86 21 58175656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026