Myopia, Progressive
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESingle vision lens
Wear single vision lens
DEVICE+2D PDL
Wear Peripheral defocus lense with +2D
DEVICE+3D PDL
Wear Peripheral defocus lense with +3D
DEVICE+4D PDL
Wear Peripheral defocus lense with +4D
Sponsors
Tianjin Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* The subjects had spherical RE of -1.00 to -6.00 D * Astigmatism ≤ 4.00 D * Anisometropia ≤ 1.50 D\\ * Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.
Exclusion criteria
* Strabismus * Ocular limitations * Systemic abnormalities affecting vision and ocular motility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in cycloplegic objective spherical equivalent (SER) | baseline, 24 months | changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in ocular axial length | baseline, 24 months | Changes in ocular axial length from baseline between four groups. |
| visual performance | 1 day | The visual acuity of peripheral between four groups. |
Countries
China
Outcome results
None listed