An interventional study of freeform myopia control spectacles and Commercial myopia control spectacle lens (CML) in Myopia, Progressive, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Active, not recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Treatment
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.
70 studies on the registry are indexed under Myopia, Degenerative; 19 are open to participants now.
This study's planned enrollment of 180 is above the median of 121 across 56 interventional studies indexed under Myopia, Degenerative.
Browse Myopia, Degenerative studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.
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Participants enrolled in the trial must:
Exclusion Criteria:
Participants enrolled in the trial must NOT have:
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.
Device: Commercial myopia control spectacle lens (CML)
60 participants will wear the OR1 lens design for two years.
Device: freeform myopia control spectacles
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.
Device: 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.
Myoless freeform peripheral plus myopia control spectacle lens by IOT
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.
Time frame: 12 months.
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.
Time frame: 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.
Time frame: 12 months.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Eye Disease Prevention and Treatment Center