Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population

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 -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.
• Be accompanied by parents/guardians who can read and comprehend 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 cyclopentolate or topical anesthetics.
• Had strabismus and/or amblyopia.
• Cylinder more than -2.00D
• 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 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.