Clinical trial NCT06927388: Myopia Progression With Freeform Myopia Control Spectacles
Official title: Myopia Progression With Freeform Open Ring Myopia Control Spectacles Versus a Commercial Peripheral Plus Myopia Control Spectacle in Chinese Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Keywords: Myopia progression
open ring myopia control spectacle lens
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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.
* 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:

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.
* 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

Primary outcomes:
measure: myopic progression in one year
timeFrame: 12 months.
Secondary outcomes:
measure: myopia progression within myopia risk categories
timeFrame: 12 months.
measure: the wearer subjective experience
timeFrame: 12 months.
Other outcomes:
Locations:
Study officials:
References: