Influence of Rodenstock Spectacle Lenses on Myopia Progression.

NCT ID: NCT06816446

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-22
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Myopia control spectacle lens

Group Type: EXPERIMENTAL

Myopia control spectacle lens

Intervention Type: 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.

Control group

Single-vision spectacle lens

Group Type: ACTIVE_COMPARATOR

Single-vision lens

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Singapore

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Rodenstock GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Chen-Hsin Sun

Dr. Sun Chen-Hsin; Dr. Raymond Najjar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NUH

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Liyana Nur Farah Binte Makribi

Role: CONTACT

liyananf@nus.edu.sg

65162085 ext. +65

Facility Contacts

Liyana Nur Farah Binte Makribi

Role: primary

liyanaf@nus.edu.sg

65162085 ext. +65

Other Identifiers

CTS01245

Identifier Type: -

Identifier Source: org_study_id