Clinical validation of a new optical biometer for myopia control in a healthy pediatric population

AUTHORS:

Martínez-Plaza, E., Molina-Martín, A., Arias-Puente, A., & Piñero, D.P.

PUBLICATION:

Children (Basel). 2022 Nov 9;9(11):1713. doi: 10.3390/children9111713.

Study Purpose

To assess the clinical validation of the Myah device in a pediatric population by evaluating the repeatability of biometric evaluations and analyzing its agreement with the Myopia Master system

Overview

Study Design

    Observational single-visit study

# of Eyes/
Patients

• 51 children (51 eyes); mean age of 10.80 ± 3.40 years (range 5 to 18 years) • Subgroup of 30 eyes used for agreement analysis; mean age of 9.93 ± 2.97 (range 5 to 18 years

Study Device

  • Myah® (Topcon Healthcare Inc., Tokyo, Japan)
  • Myopia Master® (Oculus GmBH, Wetzlar, Germany)

Outcome Measures

Repeatability of biometric measurements of flat (K1) and steep (K2) corneal radius, white to-white (WTW) distance, and axial length (AL) and agreement of these parameters to a second device

Results

  • Repeated measurements of K1, K2 and WTW performed with the Myah device showed an excellent intraclass correlation coefficient (ICC), equal to or higher than 0.97 in all cases, obtaining an intrasubject standard deviation (Sw) of 0.02 mm, 0.02 mm, and 0.07 mm, respectively (Table 2)
  • For AL measurements, the repeatability of the Myah device was even better than that of the previous parameters (K1, K2, WTW), showing a Sw of 0.02 mm and an ICC of 1 (Table 2)
  • The mean values and standard deviation were 7.85 ± 0.23 mm and 7.87 ± 0.23 mm for the K1 measurements; 7.67 ± 0.23 mm and 7.73 ± 0.23 mm for the K2 measurements; 12.19 ± 0.40 mm and 11.99 ± 0.30 mm for the WTW measurements; and 23.86 ± 0.97 mm and 23.83 ± 0.94 mm for the AL measurements using the Myah and Myopia Master devices, respectively
  • No significant differences were found for the K1 measurement between both devices (p = 0.16). Contrarily, the mean value of K2 was significantly higher for the Myopia Master device (p < 0.001), and the mean values of WTW and AL were significantly higher for the Myah device (p < 0.001 and p = 0.009, respectively)

IMOvifa reduced measurement time by

39%

TABLE 1

TABLE 1.

Adapted from Children (Basel). 2022 Nov 9;9(11):1713. doi: 10.3390/children9111713

TABLE 2

Adapted from Children (Basel). 2022 Nov 9;9(11):1713. doi: 10.3390/children9111713.

Conclusions

• Myah device provides consistent measurements of corneal radius, WTW distance and AL in a healthy pediatric population, validating their usefulness in clinical practice • Repeatability found for measuring AL with the Myah device in children is comparable with that of other biometers available in the market. Eye care practitioners involved in myopia control can be confident in using the Myah device to evaluate the progression of myopia in children

Product Comparison

Rotary Prism
Autorefraction

Keratometry

Auto Measure

Auto Right/Left

Full Auto
Align/Measurement

Rotary Prism
Autorefraction

Keratometry

Corneal Topography

Auto Measure

Auto Right/Left

Full Auto
Align/Measurement

Rotary Prism
Autorefraction

Keratometry

Auto Measure

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Lorem Ipsum

X.X”

360° Rotating
Touchscreen

Control Lever

X.X”

LCD Screen Panel

Wavefront

Control Lever

8.5″

LCD Screen Panel

Lorem Ipsum

EMR

EMR Connectivity

Corneal Aberrometry

Ocular Aberrometry

Pupillometry

Tear Film Assessment

Viewer Software Available

EMR

EMR Connectivity

EMR

EMR Connectivity

The Topcon Healthcare Ophthalmology Solution

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The Topcon Healthcare Myopia Solution

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