Influence of Rodenstock Spectacle Lenses on Myopia Progression.

NCT06816446 | Recruiting

• 1 other identifier: CTS01245
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Myopia

Keywords

Myopia; Myopia control; Lenses; Light

Outcome Measures

Primary Outcomes (1)

• Spherical equivalent refraction

  Change in spherical equivalent refraction

  2 years

Secondary Outcomes (7)

• Axial length

  2 years

• Peripheral refraction

  2 years

• Choroidal thickness

  2 years

• Visual acuity

  1 year

• Contrast sensitivity

  1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

Myopia control spectacle lens

Device: Myopia control spectacle lens

Control group

ACTIVE COMPARATOR

Single-vision spectacle lens

Device: Single-vision lens

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rodenstock GmbH: lead
• National University of Singapore: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (1)

NUH

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Liyana Nur Farah Binte Makribi

CONTACT

65162085; liyananf@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sun Chen-Hsin; Dr. Raymond Najjar

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)