Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: With-the-Rule Astigmatic Defocus Lens, With-the-Rule Astigmatic Defocus Lens (Non-plano), Single Vision.
- Who it may be relevant to
- Registry conditions: Hyperopic Astigmatism. Basic parameters: 6 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other With-the-Rule Astigmatic Defocus Lens
The lens was prescribed with 0.00 diopters - Other With-the-Rule Astigmatic Defocus Lens (Non-plano)
The magnitude of the central optical zone completely corrected their refractive errors under baseline cycloplegia - Other Single Vision
The lenses do not have corrective functions
Primary outcome measures
- Changes in the axial length [Time frame: baseline, 6-month, 12-month, 18-month, 24-month]
- Change in the spherical equivalent [Time frame: Baseline, 6-month, 12-month, 18-month, 24-month]
Secondary outcome measures (2)
- Changes in axial length [Time frame: Baseline, 6-month, 12-month, 18-month, 24-month]
- Change in equivalent spherical [Time frame: Baseline, 6-month, 12-month, 18-month, 24-month]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Systemic diseases or eye diseases
- Received myopia control treatment through medication or optical
- Any situation where participation is deemed unsuitable by the investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07682974 · WRAD2026