Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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

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Myopia, Progressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

The subjects are randomized to wear SV lens

Group Type PLACEBO_COMPARATOR

Single vision lens

Intervention Type DEVICE

Wear single vision lens

experimental group +2D

The subjects are randomized to wear special designed lens with +2D Peripheral Defocus.

Group Type EXPERIMENTAL

+2D PDL

Intervention Type DEVICE

Wear Peripheral defocus lense with +2D

experimental group +3D

The subjects are randomized to wear special designed lens with +3D Peripheral Defocus.

Group Type EXPERIMENTAL

+3D PDL

Intervention Type DEVICE

Wear Peripheral defocus lense with +3D

experimental group +4D

The subjects are randomized to wear special designed lens with +4D Peripheral Defocus.

Group Type EXPERIMENTAL

+4D PDL

Intervention Type DEVICE

Wear Peripheral defocus lense with +4D

Interventions

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Single vision lens

Wear single vision lens

Intervention Type DEVICE

+2D PDL

Wear Peripheral defocus lense with +2D

Intervention Type DEVICE

+3D PDL

Wear Peripheral defocus lense with +3D

Intervention Type DEVICE

+4D PDL

Wear Peripheral defocus lense with +4D

Intervention Type DEVICE

Eligibility Criteria

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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.