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 Title of Study: “Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: September 30, 2022
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.
- Device: Single vision lens
- Wear single vision lens
- Device: +2D PDL
- Wear Peripheral defocus lense with +2D
- Device: +3D PDL
- Wear Peripheral defocus lense with +3D
- Device: +4D PDL
- Wear Peripheral defocus lense with +4D
Arms, Groups and Cohorts
- Placebo Comparator: Control group
- The subjects are randomized to wear SV lens
- Experimental: experimental group +2D
- The subjects are randomized to wear special designed lens with +2D Peripheral Defocus.
- Experimental: experimental group +3D
- The subjects are randomized to wear special designed lens with +3D Peripheral Defocus.
- Experimental: experimental group +4D
- The subjects are randomized to wear special designed lens with +4D Peripheral Defocus.
Clinical Trial Outcome Measures
- changes in cycloplegic objective spherical equivalent (SER)
- Time Frame: baseline, 24 months
- changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
- changes in ocular axial length
- Time Frame: baseline, 24 months
- Changes in ocular axial length from baseline between four groups.
- visual performance
- Time Frame: 1 day
- The visual acuity of peripheral between four groups.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 15 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Tianjin Eye Hospital
- Provider of Information About this Clinical Study
- Overall Official(s)
- Lihua Li, Principal Investigator, Tianjin Eye Hospital
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