A Pilot Evaluation of Refractive Error Progression in Pre-Myopic Children in Singapore With and Without Myopia Control Spectacles

A Pilot Evaluation of Refractive Error Progression in Pre-Myopic Children in Singapore With and Without Myopia Control Spectacles

This study aims to find out whether ZEISS MyoActive lenses can help prevent short-sightedness from developing in children. We aim to recruit at least 50 children in total for this study.

Myopia (short-sightedness) is becoming increasingly common in children worldwide. Early onset of myopia often leads to faster progression and a higher chance of developing high myopia, which increases the risk of serious eye conditions that can affect vision in adulthood, such as retinal detachment, glaucoma, and cataracts. Current treatments can slow the worsening of short-sightedness once children become myopic, but there is limited evidence on whether early intervention can delay myopia from developing in the first place.

This study will compare two types of commonly used spectacle lenses:

ZEISS MyoActive lenses, which are designed to provide a type of optical signal that may reduce the worsening of short-sightedness; and Standard single-vision lenses, which are the usual lenses prescribed for clear vision.

Children who join the study will be randomly assigned to wear one of these two lens types for 12 months. They will attend regular check-ups during this time so we can monitor their eye health and vision.

By randomly assigning children to one of these two lens types and following them over 12 months, we aim to determine whether ZEISS MyoActive lenses:

reduce the likelihood of developing short-sightedness, slow changes in how short-sighted a child's eyes are becoming and eye growth, and are safe, comfortable, and well-tolerated for everyday use. The findings from this study may help improve early myopia prevention strategies and potentially reduce future risks of high myopia and its associated eye conditions.

Inclusion Criteria

Participants enrolled in the trial must:

1. be accompanied by a parent or guardian who is able to read and comprehend English and sign a record of informed consent/assent;
2. be able to understand and participate in the Assent process;
3. at baseline, be within the age range of 6 to 12 years old inclusive;
4. No prior spectacle correction
5. Cycloplegic spherical equivalent (SE) 0.00 to + 2.00 D
6. Astigmatism of less than -1.50D
7. Anisometropia of not more than 1.50D
8. At least 1 parent or more with myopia

Exclusion Criteria

Participants enrolled in the trial must NOT have:

• Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error;
• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus.
• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the study. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the study product is used.
• History of eye trauma
• Amblyopia
• Strabismus
• History of any form of optical correction
• Any concomitant myopia control treatment including atropine eyedrops, contact lenses or other myopia control glasses.

The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the study requirements or it is believed to be in the participant's best interests.