Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

Myopia, Progressive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05373693
• Other study ID #: TJYYLL-2018-04
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Device:
• Single vision lens
Wear single vision lens
• +2D PDL
Wear Peripheral defocus lense with +2D
• +3D PDL
Wear Peripheral defocus lense with +3D
• +4D PDL
Wear Peripheral defocus lense with +4D

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in cycloplegic objective spherical equivalent (SER)	changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.	baseline, 24 months
Secondary	changes in ocular axial length	Changes in ocular axial length from baseline between four groups.	baseline, 24 months
Secondary	visual performance	The visual acuity of peripheral between four groups.	1 day