Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: Single vision lens; Device: +2D PDL; Device: +3D PDL; Device: +4D PDL

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300020
    • Tianjin Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; The subjects are randomized to wear SV lens	Device: Single vision lens; Wear single vision lens
Experimental: experimental group +2D; The subjects are randomized to wear special designed lens with +2D Peripheral Defocus.	Device: +2D PDL; Wear Peripheral defocus lense with +2D
Experimental: experimental group +3D; The subjects are randomized to wear special designed lens with +3D Peripheral Defocus.	Device: +3D PDL; Wear Peripheral defocus lense with +3D
Experimental: experimental group +4D; The subjects are randomized to wear special designed lens with +4D Peripheral Defocus.	Device: +4D PDL; Wear Peripheral defocus lense with +4D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in cycloplegic objective spherical equivalent (SER)	changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.	baseline, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in ocular axial length	Changes in ocular axial length from baseline between four groups.	baseline, 24 months
visual performance	The visual acuity of peripheral between four groups.	1 day

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Principal Investigator: Lihua Li, Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: TJYYLL-2018-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No