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Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children

Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07682974
Enrollment
117
Registered
2026-07-06
Start date
2026-07-01
Completion date
2030-07-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperopic Astigmatism

Brief summary

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

OTHERWith-the-Rule Astigmatic Defocus Lens

The lens was prescribed with 0.00 diopters

OTHERWith-the-Rule Astigmatic Defocus Lens (Non-plano)

The magnitude of the central optical zone completely corrected their refractive errors under baseline cycloplegia

The lenses do not have corrective functions

Sponsors

He Eye Hospital
Lead SponsorOTHER
He Eye Specialist Hospital
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the axial lengthbaseline, 6-month, 12-month, 18-month, 24-monthThe changes in axial length of the eyes in the experimental group and the control group in the first and second years
Change in the spherical equivalentBaseline, 6-month, 12-month, 18-month, 24-monthThe changes in spherical equivalent in the experimental group and the control group in the first and second years

Secondary

MeasureTime frameDescription
Changes in axial lengthBaseline, 6-month, 12-month, 18-month, 24-monthChanges in axial length from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.
Change in equivalent sphericalBaseline, 6-month, 12-month, 18-month, 24-monthChanges in spherical equivalent refraction from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.

Contacts

CONTACTGuanghao Qin
qinguanghao2020@163.com+8618842664420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026