Status:
ACTIVE_NOT_RECRUITING
Myopia Progression With Freeform Myopia Control Spectacles
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Conditions:
Myopia, Progressive
Eligibility:
All Genders
6-12 years
Phase:
NA
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06927388
Start Date
May 17 2025
End Date
September 30 2027
Last Update
December 8 2025
Active Locations (1)
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1
Xiangui He
Shanghai, China, 200040