The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.
The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are planned. First, objective testing will be utilized to assess the effect of Bestivue PDL lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 D power and single vision lenses.In the second stage, the same children participants will wear either single or Bestvue PDL lenses with one of the four plus power designs for 2 years. Their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. Outcomes of these studies should inform whether Bestivue PDL lenses are effective in myopia control while affording adequate visual comfort and performance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
160
Wear single vision lens
Wear Peripheral defocus lense with +2D
Wear Peripheral defocus lense with +3D
Tianjin Eye Hospital
Tianjin, China
changes in cycloplegic objective spherical equivalent (SER)
changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
Time frame: baseline, 24 months
changes in ocular axial length
Changes in ocular axial length from baseline between four groups.
Time frame: baseline, 24 months
visual performance
The visual acuity of peripheral between four groups.
Time frame: 1 day
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Wear Peripheral defocus lense with +4D