Myopia, ProgressiveNCT05894382
Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control
A study testing Double Helix Design Defocus Lens Spectacle (RACE) and single-vision spetacle lens in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Double Helix Design Defocus Lens Spectacle (RACE) and single-vision spetacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2023to 31 Dec 2026
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Race: Chinese children and adolescents.
- Age 6-13 years, gender unrestricted.
- Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
- Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
- Refractive astigmatism and astigmatism are no more than 1.5D.
- During the study period, willing to wear glasses provided by the researcher only (>10 hours) and without additional interventions.
- Willing to be randomly assigned.
- Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.
Who cannot join
- Allergic or intolerant to medications used for ciliary muscle paralysis.
- Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study.
- Received defocus lenses for nearsightedness treatment in the past.
- Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
- History of eye surgery (including strabismus correction surgery).
- Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
- Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
- Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study on the Effectiveness, Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents, and Control of Myopia.
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.
- Conditions
- Myopia, Progressive
- Being tested
- Double Helix Design Defocus Lens Spectacle (RACE), single-vision spetacle lens
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Helix Design Defocus Lens Spectacle (RACE)Device
Double Helix Design Defocus Lens Spectacle wearing more than 10h/day.
single-vision spetacle lensDevice
single-vision spetacle lens wearing more than 10h/day.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Double Helix Design Defocus Lens Spectacle (RACE) for 2 years Receives: Device: Double Helix Design Defocus Lens Spectacle (RACE) |
| Group B | Placebo comparator | 1. st year: single-vision spectacle lenses
2. nd year: double helix design defocus lens spectacle (RACE) Receives: Device: Double Helix Design Defocus Lens Spectacle (RACE); Device: single-vision spetacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalent change
cycloplegic SE change
Measured: 1 year
Secondary outcomes (2)
Axial Length change
Measured: 1 year
Visual Acuity change
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start3 Jun 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894382
- Sponsor's protocol ID
- 20230421v1.3
- Status last verified
- May 2025
- First submitted
- 30 May 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effectiveness, Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents, and Control of Myopia.
- ClinicalTrials.gov ID
- NCT05894382
- Acronym / sponsor ID
- 20230421v1.3
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2023 (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.
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Double Helix Design Defocus Lens Spectacle (RACE)Double Helix Design Defocus Lens Spectacle (RACE) for 2 years |
| Group B | Placebo comparator | Device: Double Helix Design Defocus Lens Spectacle (RACE), Device: single-vision spetacle lens1. st year: single-vision spectacle lenses 2. nd year: double helix design defocus lens spectacle (RACE) |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Race: Chinese children and adolescents.
- Age 6-13 years, gender unrestricted.
- Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
- Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
- Refractive astigmatism and astigmatism are no more than 1.5D.
Key exclusion criteria (8 listed)
- Allergic or intolerant to medications used for ciliary muscle paralysis.
- Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study.
- Received defocus lenses for nearsightedness treatment in the past.
- Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
- History of eye surgery (including strabismus correction surgery).
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 |
|---|---|---|
| Double Helix Design Defocus Lens Spectacle (RACE)Double Helix Design Defocus Lens Spectacle wearing more than 10h/day. | Device | Group A, Group B |
| single-vision spetacle lenssingle-vision spetacle lens wearing more than 10h/day. | Device | Group B |
Primary outcome
Spherical Equivalent change
Time frame: 1 year
cycloplegic SE change
2 secondary outcomes
Axial Length change
Time frame: 1 year
Visual Acuity change
Time frame: 1 year
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 8 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Helix Design Defocus Lens Spectacle (RACE) and single-vision spetacle lens in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical Equivalent change (time frame: 1 year). 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 8 Dec 2025.