Influence of Rodenstock Spectacle Lenses on Myopia Progression.

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

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).

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Myopia control spectacle lens; Device: Single-vision lens

• Study Type: Interventional
• Enrollment (Estimated): 185
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liyana Nur Farah Binte Makribi; Phone Number: +65 65162085; Email: liyananf@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • NUH
    • Contact: Liyana Nur Farah Binte Makribi; Phone Number: +65 65162085; Email: liyanaf@nus.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Single-vision spectacle lens	Device: Single-vision lens; 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.
Experimental: Intervention group; Myopia control spectacle lens	Device: Myopia control spectacle lens; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical equivalent refraction	Change in spherical equivalent refraction	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Change in axial length from baseline	2 years
Peripheral refraction	Change in peripheral refraction from baseline	2 years
Choroidal thickness	Change of choroidal thickness from baseline	2 years
Visual acuity	Difference in central visual acuity between single vision lenses and myopia control lenses	1 year
Contrast sensitivity	Difference in contrast sensitivity between single vision lenses and myopia control lenses	1 year
Visual comfort	Difference in visual comfort between single vision lenses and myopia control lenses	1 year
Light exposure	Impact of light exposure characteristics on myopia progression	2 years

Collaborators and Investigators

• Sponsor: Rodenstock GmbH
• Collaborators: National University Hospital, Singapore; National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Myopia; Light; Myopia control; Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CTS01245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Team is undecided whether to share or not share the data. This may be amended.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No