Hyperopic AstigmatismNCT07682974
Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children
A study testing With-the-Rule Astigmatic Defocus Lens, With-the-Rule Astigmatic Defocus Lens (Non-plano) and Single Vision in people with Hyperopic Astigmatism, run by He Eye Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopic Astigmatism
- What is being tested?
- With-the-Rule Astigmatic Defocus Lens, With-the-Rule Astigmatic Defocus Lens (Non-plano) and Single Vision
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Systemic diseases or eye diseases
- Received myopia control treatment through medication or optical
- Any situation where participation is deemed unsuitable by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- With-the-Rule Astigmatic Defocus Lens, With-the-Rule Astigmatic Defocus Lens (Non-plano), Single Vision
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With-the-Rule Astigmatic Defocus LensOther
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 VisionOther
The lenses do not have corrective functions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Single Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, 6-month, 12-month, 18-month, 24-month
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 6-month, 12-month, 18-month, 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperopic AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- He Eye Specialist Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682974
- Sponsor's protocol ID
- WRAD2026
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of WRAD Lens on Axial Growth and Refraction in Low-hyperopic Chinese Children
- ClinicalTrials.gov ID
- NCT07682974
- Acronym / sponsor ID
- WRAD2026
- Conditions
- Hyperopic Astigmatism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Collaborators
- He Eye Specialist Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: With-the-Rule Astigmatic Defocus LensParticipants 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 |
| Group B | Experimental | Other: With-the-Rule Astigmatic Defocus Lens (Non-plano)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 |
| Group C (control group) | Placebo comparator | Other: Single VisionParticipants will be wearing traditional single vision lens, lens has no correction function. It is recommended to wear it for ≥ 10 hours per day |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Systemic diseases or eye diseases
- Received myopia control treatment through medication or optical
- Any situation where participation is deemed unsuitable by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With-the-Rule Astigmatic Defocus LensThe lens was prescribed with 0.00 diopters | Other | Group A |
| With-the-Rule Astigmatic Defocus Lens (Non-plano)The magnitude of the central optical zone completely corrected their refractive errors under baseline cycloplegia | Other | Group B |
| Single VisionThe lenses do not have corrective functions | Other | Group C (control group) |
Primary outcome
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
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hyperopic Astigmatism
Active, not recruiting
Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Hyperopia, High Astigmatism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing With-the-Rule Astigmatic Defocus Lens, With-the-Rule Astigmatic Defocus Lens (Non-plano) and Single Vision in people with Hyperopic Astigmatism, run by He Eye Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guanghao Qin (+8618842664420, qinguanghao2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the axial length (time frame: baseline, 6-month, 12-month, 18-month, 24-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.