Myopia, ProgressiveNCT06927388
Myopia Progression With Freeform Myopia Control Spectacles
A study of Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML). Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2025to 30 Sep 2027
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants enrolled in the trial must:
- be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
- For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
- be cycloplegic autorefraction spherical component -0.50 D to -4.00D, cylinder no more than -1.50D
- be accompanied by parents/guardians who can read and comprehend Chinese and give informed consent as demonstrated by signing a record of informed consent.
- be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
Show all 9Show fewer
- have ocular health findings considered to be "normal".
- be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
- be willing to wear the spectacles provided by the investigators for all waking hours.
Who cannot join
- Participants enrolled in the trial must NOT have:
- a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics.
- had strabismus and/or amblyopia.
- Anisometropia greater than 1.50D spherical equivalent
- had previous eye surgery (including strabismus surgery).
- any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.
Show all 12Show fewer
- had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.
- current orthoptic treatment or vision training.
- any anatomical, skin or other condition that would impact on the wearing of spectacles.
- Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
- Currently enrolled in another clinical trial.
- No previous myopia management intervention or treatment within 3 months of enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myopia Progression With Freeform Open Ring Myopia Control Spectacles Versus a Commercial Peripheral Plus Myopia Control Spectacle in Chinese Children
This is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).
Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group participants wearing CML will be randomised to wear either OR1 or OR2 lens designs; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months.
- Conditions
- Myopia, Progressive
- Being tested
- freeform myopia control spectacles, Commercial myopia control spectacle lens (CML)
- Keywords
- Myopia progression, open ring myopia control spectacle 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.
freeform myopia control spectaclesDevice
The open ring freeform myopia control spectacle lens designs incorporate positively powered cylindrical annular refractive elements (CARE) on the back surface with a superiorly positioned opening in each CARE. The CARE provides an effective optical myopic defocus signal for myopia control and the ring opening facilitates a defocus free zone to aid a smoother visual free transition from downgaze through to upgaze (far) vision for the wearer. The OR designs provide a difference in area and strength of myopia defocus by altering design parameters i.e. zone widths and zone powers. The OR2 and OR3 designs have wider zones and/or higher zone powers than OR1.
Commercial myopia control spectacle lens (CML)Device
Myoless freeform peripheral plus myopia control spectacle lens by IOT
| Study group | Role | What they receive |
|---|---|---|
| Group 1：wear the commercial peripheral plus myopia control lens (CML). | Active comparator | 60 participants will wear the commercial peripheral plus myopia control lens (CML) in the first year. CML will be randomised to wear either OR1 or OR2 lens designs at the second year. Receives: Device: Commercial myopia control spectacle lens (CML) |
| Group 2 wear the Open Ring 1 (OR1) lens | Experimental | 60 participants will wear the OR1 lens design for two years. Receives: Device: freeform myopia control spectacles |
| Group 3 wear the Open Ring 2 (OR2) lens | Experimental | 60 participants will wear the OR2 lens design in the first year and wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months. Receives: Device: freeform myopia control spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
myopic progression in one year
The primary outcome measure of this study is myopic progression in one year. This is expressed as the change in spherical equivalent refractive state from baseline levels. Spherical equivalent refraction will be taken as the mean of the spherical equivalent refraction of five, reliable, cycloplegic autorefraction measurements on each eye. Myopia progression is also expressed as the change in axial length from baseline levels. Myopia progression is characterised by ocular anatomical changes, the most notable being increased axial length. This will be measured at 6 monthly intervals.
Measured: 12 months.
Secondary outcomes (2)
myopia progression within myopia risk categories
A secondary endpoint is myopia progression within myopia risk categories. Participants risk of progression will be assessed at baseline using variables such as axial length, central refraction, age, parental myopia, gender. Age, axial length percentiles and expected progression, based on published online calculators, will be converted to risk scores and categorised as low medium and high risk.
Measured: 12 months.
the wearer subjective experience
Another secondary endpoint is the wearer subjective experience which is evaluated using a subjective quality of vision scale for various activities. Both a 1-10 scale (where 1 is poor and 10 is excellent) and a Likert scale will be used and data collected at each study visit.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start17 May 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (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
- Model description
- This is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML). Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group participants wearing CML will be randomised to wear either OR1 or OR2 lens designs; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 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
- NCT06927388
- Sponsor's protocol ID
- CRTC2024-02
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- 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
- Myopia Progression With Freeform Open Ring Myopia Control Spectacles Versus a Commercial Peripheral Plus Myopia Control Spectacle in Chinese Children
- ClinicalTrials.gov ID
- NCT06927388
- Acronym / sponsor ID
- CRTC2024-02
- Conditions
- Myopia, Progressive
- Keywords
- Myopia progression, open ring myopia control spectacle lens
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 17 May 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Apr 2025 (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 is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).
Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group participants wearing CML will be randomised to wear either OR1 or OR2 lens designs; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML). Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group participants wearing CML will be randomised to wear either OR1 or OR2 lens designs; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months.
| Arm | Type | Receives |
|---|---|---|
| Group 1：wear the commercial peripheral plus myopia control lens (CML). | Active comparator | Device: Commercial myopia control spectacle lens (CML)60 participants will wear the commercial peripheral plus myopia control lens (CML) in the first year. CML will be randomised to wear either OR1 or OR2 lens designs at the second year. |
| Group 2 wear the Open Ring 1 (OR1) lens | Experimental | Device: freeform myopia control spectacles60 participants will wear the OR1 lens design for two years. |
| Group 3 wear the Open Ring 2 (OR2) lens | Experimental | Device: freeform myopia control spectacles60 participants will wear the OR2 lens design in the first year and wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
- For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
- be cycloplegic autorefraction spherical component -0.50 D to -4.00D, cylinder no more than -1.50D
- be accompanied by parents/guardians who can read and comprehend Chinese and give informed consent as demonstrated by signing a record of informed consent.
- be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
Key exclusion criteria (12 listed)
- a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics.
- had strabismus and/or amblyopia.
- Anisometropia greater than 1.50D spherical equivalent
- had previous eye surgery (including strabismus surgery).
- any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.
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 |
|---|---|---|
| freeform myopia control spectaclesThe open ring freeform myopia control spectacle lens designs incorporate positively powered cylindrical annular refractive elements (CARE) on the back surface with a superiorly positioned opening in each CARE. The CARE provides an effective optical myopic defocus signal for myopia control and the ring opening facilitates a defocus free zone to aid a smoother visual free transition from downgaze through to upgaze (far) vision for the wearer. The OR designs provide a difference in area and strength of myopia defocus by altering design parameters i.e. zone widths and zone powers. The OR2 and OR3 designs have wider zones and/or higher zone powers than OR1. | Device | Group 2 wear the Open Ring 1 (OR1) lens, Group 3 wear the Open Ring 2 (OR2) lens |
| Commercial myopia control spectacle lens (CML)Myoless freeform peripheral plus myopia control spectacle lens by IOT | Device | Group 1：wear the commercial peripheral plus myopia control lens (CML). |
Primary outcome
myopic progression in one year
Time frame: 12 months.
The primary outcome measure of this study is myopic progression in one year. This is expressed as the change in spherical equivalent refractive state from baseline levels. Spherical equivalent refraction will be taken as the mean of the spherical equivalent refraction of five, reliable, cycloplegic autorefraction measurements on each eye. Myopia progression is also expressed as the change in axial length from baseline levels. Myopia progression is characterised by ocular anatomical changes, the most notable being increased axial length. This will be measured at 6 monthly intervals.
2 secondary outcomes
myopia progression within myopia risk categories
Time frame: 12 months.
the wearer subjective experience
Time frame: 12 months.
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.
Related trials for Myopia, Progressive
RecruitingPhase 2
Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia
Myopia Progressing
Active, not recruitingPhase 3
MAD Trial: Myopia Atropine Dose
Progressive Myopia
Active, not recruiting
Myopia Control With a Innovative Spectacle Lens - A Cessation Study
Myopia Progressing
Active, not recruitingObservational study
Dynamic Pupil Variations and the Efficacy of Peripheral Defocus Spectacle Lenses in Slowing Myopia Progression
Myopia Progressing
Active, not recruiting
Evaluation of the Safety and Efficacy of the D.D.C Dual-control Technology Spectacle Lenses in Delaying the Progression of Myopia: a Randomized Controlled Trial
Myopia, Progressive
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 of 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 9 inclusion and 12 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. 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?
myopic progression in one year (time frame: 12 months.). 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.