Myopia Progression With Freeform Myopia Control Spectacles
NCT ID: NCT06927388
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
180 participants
INTERVENTIONAL
2025-05-17
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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Group 1：wear the commercial peripheral plus myopia control 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.
Commercial myopia control spectacle lens (CML)
Myoless freeform peripheral plus myopia control spectacle lens by IOT
Group 2 wear the Open Ring 1 (OR1) lens
60 participants will wear the OR1 lens design for two years.
freeform myopia control spectacles
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.
Group 3 wear the Open Ring 2 (OR2) lens
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.
freeform myopia control spectacles
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.
Interventions
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freeform myopia control spectacles
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)
Myoless freeform peripheral plus myopia control spectacle lens by IOT
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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
6 Years
12 Years
ALL
Yes
Sponsors
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Shanghai Eye Disease Prevention and Treatment Center
OTHER
Responsible Party
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Locations
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Xiangui He
Shanghai, , China
Countries
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Other Identifiers
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CRTC2024-02
Identifier Type: -
Identifier Source: org_study_id
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