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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperopic Astigmatism
• Intervention / Treatment: Other: With-the-Rule Astigmatic Defocus Lens; Other: With-the-Rule Astigmatic Defocus Lens (Non-plano); Other: Single Vision

• Study Type: Interventional
• Enrollment (Estimated): 117
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guanghao Qin; Phone Number: +8618842664420; Email: qinguanghao2020@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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; The lens was prescribed with 0.00 diopters
Experimental: Group B; 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); The magnitude of the central optical zone completely corrected their refractive errors under baseline cycloplegia
Placebo Comparator: Group C (control group); 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; The lenses do not have corrective functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6-month, 12-month, 18-month, 24-month
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.	Baseline, 6-month, 12-month, 18-month, 24-month

Collaborators and Investigators

• Sponsor: He Eye Hospital
• Collaborators: He Eye Specialist Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Musculoskeletal and Neural Physiological Phenomena; Cell Physiological Phenomena; Biochemical Phenomena; Chemical Phenomena; Nervous System Physiological Phenomena; Ocular Physiological Phenomena; Sensation; Signal Transduction; Light Signal Transduction; Vision, Ocular
• Other Study ID Numbers: WRAD2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No