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NCT Number: NCT06816446

Influence of Rodenstock Spectacle Lenses on Myopia Progression.

The prevalence of myopia in Singapore is among the highest in the world, with 65 percent of our children being myopic by Primary 6, and 83 percent of young adults being myopic. As such, Singapore is often labelled as the "Myopia Capital of the World". By 2050, it is projected that 80 to 90 per cent of all Singaporean adults above 18 years old will be myopic and 15 to 25 percent of these individuals may have high myopia.

High myopia (spherical equivalent refraction ≤ -5 D) puts one at risk of many eye disorders later in life, such as early cataracts, glaucoma and macular degeneration. These complications often cause significant morbidity and may even be sight-threatening. Hence there is an urgent and growing need for synergistic efforts to counter myopia.

The goal of this clinical trial is to test the efficacy of spectacle lenses in controlling the progression of myopia in children (aged 6-12 years) over a period of 2 years. In addition, this trial aims to evaluate the impact of these spectacle lenses on central visual performance and visual comfort.

Therefore, in this randomised, double-masked clinical trial, one hundred and eighty-five (n=185) subjects aged 6-12 years with mild or moderate myopia (< -5D) will be randomised in a 1:1 allocation ratio into three strata defined by age 6-8, 8-10 and 10-12 years to ensure age balance between the two arms (control group - single vision lenses and intervention group - myopia control lenses, gender matched). In the control group, after one year (12 months) of wearing single vision lenses, the children will switch to the myopia control lenses (crossover design).

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NUH

Singapore

Location status: Recruiting

Location contact

Liyana Nur Farah Binte Makribi

CONTACT

[email protected]

65162085 ext. +65

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All myopic children aged 6-12 years old
  • Treatment naïve
  • Sphere: -0.5 D till -5.00 D
  • Anisometropia < 1.5D
  • Astigmatism > -1.5D
  • Monocular best corrected visual acuity +0.1 logMAR or better, and binocular visual acuity 0.0 logMAR or better

Exclusion criteria

  • On current myopia control treatments
  • Any diagnosed ocular conditions besides myopia or astigmatism.
  • No diagnosed ocularmotor conditions (Nystagmus, strabismus, etc.)
  • Any diagnosed chronic physical or mental disabilities
  • Contraindication in cycloplegia (high IOP, etc.)
  • Corneal astigmatism > 1.5 D; irregular astigmatism

Treatment and study plan

Myopia control spectacle lens

Device

The intervention group will wear specially designed lenses that aim to slow the progression of myopia. Follow-up visits will take place at regular intervals.

Single-vision lens

Device

The control group will wear single vision lenses for one year. They will then switch to the myopia control lens for a further year. Follow-up visits will take place at regular intervals.

Primary outcomes

  1. Spherical equivalent refraction

    Time frame: 2 years

    Change in spherical equivalent refraction

Secondary outcomes

  1. Axial length

    Time frame: 2 years

    Change in axial length from baseline

  2. Peripheral refraction

    Time frame: 2 years

    Change in peripheral refraction from baseline

  3. Choroidal thickness

    Time frame: 2 years

    Change of choroidal thickness from baseline

  4. Visual acuity

    Time frame: 1 year

    Difference in central visual acuity between single vision lenses and myopia control lenses

  5. Contrast sensitivity

    Time frame: 1 year

    Difference in contrast sensitivity between single vision lenses and myopia control lenses

  6. Visual comfort

    Time frame: 1 year

    Difference in visual comfort between single vision lenses and myopia control lenses

  7. Light exposure

    Time frame: 2 years

    Impact of light exposure characteristics on myopia progression

Study contacts

Contact information is provided by the study sponsor or research team.

Liyana Nur Farah Binte Makribi

CONTACT

[email protected]

65162085 ext. +65

Sponsors and collaborators

Lead sponsor

Rodenstock GmbH

Industry

Collaborators

  • National University Hospital, Singapore
  • National University of Singapore

Registry information

Official study title

Testing the Efficacy of Rodenstock Spectacle Lenses in Myopia Progression: a Two Year Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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