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NCT Number: NCT07682974

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

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.

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Key information

Conditions

Hyperopic Astigmatism Astigmatism Eye Diseases Refractive Errors

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

With-the-Rule Astigmatic Defocus Lens

Other

The lens was prescribed with 0.00 diopters

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

Other

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

Single Vision

Other

The lenses do not have corrective functions

Primary outcomes

  1. Changes in the axial length

    Time frame: baseline, 6-month, 12-month, 18-month, 24-month

    The changes in axial length of the eyes in the experimental group and the control group in the first and second years

  2. Change in the spherical equivalent

    Time frame: Baseline, 6-month, 12-month, 18-month, 24-month

    The changes in spherical equivalent in the experimental group and the control group in the first and second years

Secondary outcomes

  1. Changes in axial length

    Time frame: Baseline, 6-month, 12-month, 18-month, 24-month

    Changes in axial length from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.

  2. Change in equivalent spherical

    Time frame: Baseline, 6-month, 12-month, 18-month, 24-month

    Changes in spherical equivalent refraction from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Guanghao Qin

CONTACT

[email protected]

+8618842664420

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Collaborators

  • He Eye Specialist Hospital

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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