NCT05373693

Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Tianjin Eye Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DEVICE	Single 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

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2022-05-13
• Last updated: 2022-05-13

Locations

1 site across 1 country: China