Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

Tianjin Eye Hospital

Status: Unknown

Conditions: Myopia, Progressive

Treatments: Device: Single vision lens; Device: +2D PDL; Device: +4D PDL; Device: +3D PDL

Study type: Interventional

Funder types: Other

Identifiers

NCT05373693

TJYYLL-2018-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

The subjects are randomized to wear SV lens

Treatment:

Device: Single vision lens

experimental group +2D

Experimental group

Description:

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

Treatment:

Device: +2D PDL

experimental group +3D

Experimental group

Description:

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

Treatment:

Device: +3D PDL

experimental group +4D

Experimental group

Description:

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

Treatment:

Device: +4D PDL