Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

Not Applicable

• Conditions: Myopia, Progressive
• Interventions: Device: +3D PDL; Device: Single vision lens; Device: +2D PDL; Device: +4D PDL

• Registration Number: NCT05373693
• Lead Sponsor: Tianjin Eye Hospital

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.

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2022-03
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-05-09
• Last Update Submitted: 2022-05-09
• Study First Posted: 2022-05-13
• Last Update Posted: 2022-05-13
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group +3D	+3D PDL	The subjects are randomized to wear special designed lens with +3D Peripheral Defocus.
Control group	Single vision lens	The subjects are randomized to wear SV lens
experimental group +2D	+2D PDL	The subjects are randomized to wear special designed lens with +2D Peripheral Defocus.
experimental group +4D	+4D PDL	The subjects are randomized to wear special designed lens with +4D Peripheral Defocus.

Primary Outcome Measures

Name	Time	Method
changes in cycloplegic objective spherical equivalent (SER)	baseline, 24 months	changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China