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

NCT07682974 | Not Yet Recruiting

• 1 other identifier: WRAD2026
• Study Type: interventional
• Target: 117
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperopic Astigmatism

Outcome Measures

Primary Outcomes (2)

• 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

  baseline, 6-month, 12-month, 18-month, 24-month

• Change in the spherical equivalent

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

  Baseline, 6-month, 12-month, 18-month, 24-month

Secondary Outcomes (2)

• Changes in axial length

  Baseline, 6-month, 12-month, 18-month, 24-month

• Change in equivalent spherical

  Baseline, 6-month, 12-month, 18-month, 24-month

Study Arms (3)

Group A

EXPERIMENTAL

Participants will be wearing with-the-rule astigmatic defocus lens glasses. The lens was prescribed with 0.00 diopters. It is recommended to wear it for ≥ 10 hours per day

Other: With-the-Rule Astigmatic Defocus Lens

Group B

EXPERIMENTAL

Participants will be wearing with-the-rule astigmatic defocus lens glasses (non-plano defocus spectacles); the central optical zone degree completely correct their baseline under cycloplegia refractive errors. It is recommended to wear it for ≥ 10 hours per day

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

Group C (control group)

PLACEBO COMPARATOR

Participants will be wearing traditional single vision lens, lens has no correction function. It is recommended to wear it for ≥ 10 hours per day

Other: Single Vision

Interventions

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

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

Group B

Single Vision OTHER

The lenses do not have corrective functions

Group C (control group)

With-the-Rule Astigmatic Defocus Lens OTHER

The lens was prescribed with 0.00 diopters

Group A

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Systemic diseases or eye diseases
• Received myopia control treatment through medication or optical
• Any situation where participation is deemed unsuitable by the investigator

Sponsors & Collaborators

• He Eye Hospital: lead
• He Eye Specialist Hospital: collaborator

MeSH Terms

Conditions

Astigmatism

Interventions

Vision, Ocular

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Central Study Contacts

Guanghao Qin

CONTACT

+8618842664420; qinguanghao2020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share