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

Summary

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.

Conditions

• Myopia
• Pre-myopia

Interventions

DEVICE

Zeiss MyoActive lenses

The novel ZEISS MyoActive lens was designed to introduce simultaneous myopic defocus at the retina. Early studies, including interim results from the ongoing trial NCT06563700, have shown promise in reducing myopia progression in already-myope children. However, its utility in pre-myopic children remains underexplored, and no current optical strategy has been validated for delaying the transition from pre-myopia to clinical myopia.

DEVICE

Single Vision Lenses

Patients will be fitted with a pair of plano single vision glasses.

Sponsors & Collaborators

• Duke-NUS Graduate Medical School

  collaborator OTHER

• ZEISS Vision Care

  collaborator INDUSTRY

• Singapore National Eye Centre

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-08-31

Completion

2029-02-28

Countries

• Singapore

Study Locations