Repeated low-level red light for myopia progression study

Repeated low-level red light for myopia progression study: A 1-year, in international, multicenter, multiethnic, randomized controlled trail, an IPOSC study - Repeated low-level red light for myopia progression study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58081

Enrollment

Registered

2025-02-04

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Progressive myopia, Axial length, Refractive error Myopia, Progressive myopia, Eye ball elongation, Refractive error

Interventions

The Myopia Management device used in this study is a semi-conductor laser product (Eyerising International

South Yarra, Australia), emitting low-level red-light with a wavelength of 650 ± 10 nm. Based on calculations done by the manufacturer, the device provides light at a power of 2.00 ± 0.50 mW.&nbsp

Subjects will be treated with a therapy device (the myopia management device or control sham device) 5 days a week, three minutes per session, twice/ day, with a minimum interval of 4 hours, under the

Eligibility

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1) Age: 6 to 12 years at enrolment2) Myopia: Cycloplegic Spherical equivalent refractive error -1.0 to -7.0 diopters (D) in each eye3) Anisometropia : < 1.5 D4) Astigmatism: < 1.5 D5) Best corrected visual acuity 20/25 or better6) Informed parental consent

Exclusion criteria

Exclusion criteria: 1) Ophthalmic diseases, conditions, or syndromes other than ammetropia and myelinated nerve fiber layer, or prematurity (less than 36 weeks of gestation)2) Previous use of optical or pharmacologic treatment for myopia control (e.g., defocusing spectacle or contact lenses, orthokeratology, atropine, or pirenzepine) 3) Systemic diseases (e.g., endocrine, cardiac diseases) and developmental anomalies4) Inability to attend regular follow up visits

Design outcomes

Primary

Measure	Time frame
Changes in cycloplegic spherical equivalent refractive error and changes in axial length.	—

Secondary

Measure	Time frame
Changes in the rate of spherical equivalent refractive error and axial length increase. Changes in other biometric parameters except axial length: anterior chamber depth, corneal curvature, white to white, choroidal thickness and choroidal structures. Best corrected visual acuity, intraocular pressures, ocular and systemic symptoms, ocular signs assessed by slit lamp biomicroscopy and binocular indirect ophthalmoscopy, and questionnaire for self-reported visual function.	—

Measure

Time frame

Changes in the rate of spherical equivalent refractive error and axial length increase. Changes in other biometric parameters except axial length: anterior chamber depth, corneal curvature, white to white, choroidal thickness and choroidal structures. Best corrected visual acuity, intraocular pressures, ocular and systemic symptoms, ocular signs assessed by slit lamp biomicroscopy and binocular indirect ophthalmoscopy, and questionnaire for self-reported visual function. 

—

Countries

Australia, China, India, Israel, Japan, Mexico, Nepal, Netherlands, Poland, Saudi Arabia, South Korea, Spain, Taiwan, United States

Contacts

Public ContactC.C.W. Klaver

Erasmus MC, Universitair Medisch Centrum Rotterdam

onderzoek.oogheelkunde@erasmusmc.nl010-7039995

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 16, 2026