Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedMay 13, 2022
March 1, 2022
3.3 years
April 15, 2022
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
changes in cycloplegic objective spherical equivalent (SER)
changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
baseline, 24 months
Secondary Outcomes (2)
changes in ocular axial length
baseline, 24 months
visual performance
1 day
Study Arms (4)
Control group
PLACEBO COMPARATORThe subjects are randomized to wear SV lens
experimental group +2D
EXPERIMENTALThe subjects are randomized to wear special designed lens with +2D Peripheral Defocus.
experimental group +3D
EXPERIMENTALThe subjects are randomized to wear special designed lens with +3D Peripheral Defocus.
experimental group +4D
EXPERIMENTALThe subjects are randomized to wear special designed lens with +4D Peripheral Defocus.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Strabismus
- Ocular limitations
- Systemic abnormalities affecting vision and ocular motility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Eye Hospital
Tianjin, 300020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lihua Li
Tianjin Eye Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2022
First Posted
May 13, 2022
Study Start
July 1, 2019
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
May 13, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share