Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
Primary Purpose
Myopia, Progressive
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Single vision lens
+2D PDL
+3D PDL
+4D PDL
Sponsored by
About this trial
This is an interventional prevention trial for Myopia, Progressive
Eligibility Criteria
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.
Sites / Locations
- Tianjin Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Control group
experimental group +2D
experimental group +3D
experimental group +4D
Arm Description
The subjects are randomized to wear SV lens
The subjects are randomized to wear special designed lens with +2D Peripheral Defocus.
The subjects are randomized to wear special designed lens with +3D Peripheral Defocus.
The subjects are randomized to wear special designed lens with +4D Peripheral Defocus.
Outcomes
Primary Outcome Measures
changes in cycloplegic objective spherical equivalent (SER)
changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
Secondary Outcome Measures
changes in ocular axial length
Changes in ocular axial length from baseline between four groups.
visual performance
The visual acuity of peripheral between four groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05373693
Brief Title
Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
Official Title
Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The subjects are randomized to wear SV lens
Arm Title
experimental group +2D
Arm Type
Experimental
Arm Description
The subjects are randomized to wear special designed lens with +2D Peripheral Defocus.
Arm Title
experimental group +3D
Arm Type
Experimental
Arm Description
The subjects are randomized to wear special designed lens with +3D Peripheral Defocus.
Arm Title
experimental group +4D
Arm Type
Experimental
Arm Description
The subjects are randomized to wear special designed lens with +4D Peripheral Defocus.
Intervention Type
Device
Intervention Name(s)
Single vision lens
Intervention Description
Wear single vision lens
Intervention Type
Device
Intervention Name(s)
+2D PDL
Intervention Description
Wear Peripheral defocus lense with +2D
Intervention Type
Device
Intervention Name(s)
+3D PDL
Intervention Description
Wear Peripheral defocus lense with +3D
Intervention Type
Device
Intervention Name(s)
+4D PDL
Intervention Description
Wear Peripheral defocus lense with +4D
Primary Outcome Measure Information:
Title
changes in cycloplegic objective spherical equivalent (SER)
Description
changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
Time Frame
baseline, 24 months
Secondary Outcome Measure Information:
Title
changes in ocular axial length
Description
Changes in ocular axial length from baseline between four groups.
Time Frame
baseline, 24 months
Title
visual performance
Description
The visual acuity of peripheral between four groups.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihua Li
Organizational Affiliation
Tianjin Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
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