Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children
ConditionHyperopic Astigmatism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorHe Eye Hospital
About this trial
Myopia is one of the most common visual impairments worldwide.This not only poses long-term risks to individual health but also imposes significant medical and economic burdens on society. \[6\] Therefore, delaying the onset of myopia and effectively controlling its progression has become an urgent issue that needs to be addressed.In recent years, a new type of highly aspherical lenslet (HAL) has been proposed. Its optical design includes a refractive correction area in the central region and a peripheral annular area. This annular area can form a "myopic defocus zone", increasing the myopic defocus signal around the retina. Studies have confirmed that this design can effectively slow down the progression of myopia in already myopic children. However, it is currently unclear whether this lens has a preventive effect on children who are not yet myopic but have a risk of developing myopia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 6 to 9 with low hyperopia, regardless of gender
The refractive error is between 0 and 2.00D
The best corrected visual acuity of both eyes is ≥ 0.10 LogMAR
The subjects themselves and their guardians voluntarily participated
Disqualifiers
Systemic diseases or eye diseases
Received myopia control treatment through medication or optical
Any situation where participation is deemed unsuitable by the investigator
Trial design
Design model
Parallel
Treatments tested in this trial
With-the-Rule Astigmatic Defocus Lens
Other interventionThe lens was prescribed with 0.00 diopters
With-the-Rule Astigmatic Defocus Lens (Non-plano)
Other interventionThe magnitude of the central optical zone completely corrected their refractive errors under baseline cycloplegia
Single Vision
Other interventionThe lenses do not have corrective functions
Treatment groups
117 Participants
are divided into 3 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group C (control group)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in the axial length
The changes in axial length of the eyes in the experimental group and the control group in the first and second years
Time frame
baseline, 6-month, 12-month, 18-month, 24-month2
Change in the spherical equivalent
The changes in spherical equivalent in the experimental group and the control group in the first and second years
Time frame
Baseline, 6-month, 12-month, 18-month, 24-monthSecondary outcomes
1
Changes in axial length
Changes in axial length from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.
Time frame
Baseline, 6-month, 12-month, 18-month, 24-month2
Change in equivalent spherical
Changes in spherical equivalent refraction from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.
Time frame
Baseline, 6-month, 12-month, 18-month, 24-monthLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
He Eye Hospital
Lead sponsor
He Eye Specialist Hospital
Collaborator
Source ClinicalTrials.gov
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