Myopia Progression With Freeform Myopia Control Spectacles

Shanghai Eye Disease Prevention and Treatment Center

Status: Active, not recruiting

Conditions: Myopia, Progressive

Treatments: Device: freeform myopia control spectacles; Device: Commercial myopia control spectacle lens (CML)

Study type: Interventional

Funder types: Other

Identifiers

NCT06927388

CRTC2024-02

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Group 1：wear the commercial peripheral plus myopia control lens (CML).

Active Comparator group

Description:

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.

Treatment:

Device: Commercial myopia control spectacle lens (CML)

Group 2 wear the Open Ring 1 (OR1) lens

Experimental group

Description:

60 participants will wear the OR1 lens design for two years.

Treatment:

Device: freeform myopia control spectacles

Group 3 wear the Open Ring 2 (OR2) lens

Experimental group

Description:

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.

Treatment:

Device: freeform myopia control spectacles