MyopiaX: a new blue-light therapy for myopia

Paper title: MyopiaX-1 Safety and Efficacy of a Novel Approach to Slow Juvenile Myopia Progression: A Multicenter, Randomized, Controlled Trial

Authors: Loughman J (1), Lingham G (2), Kaymak H (3,4), Lorenz K (5), Polling JR (6), Beck A (5), Carracedo G (7), Dahlmann-Noor AH (8,9), Müller PL (10,11), Flitcroft I (1); MyopiaX-1 Study Group

1. Centre for Eye Research Ireland, Sustainability and Health Research Hub, Technological University Dublin, Dublin, Ireland.
2. Centre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), The University of Western Australia, Perth, Western Australia, Australia.
3. Internationale Innovative Ophthalmochirurgie GbR, Duesseldorf, Germany.
4. Institute of Experimental Ophthalmology, Saarland University, Homburg, Saar, Germany.
5. Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
6. Department of Ophthalmology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.
7. Ocupharm Research Group, Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.
8. Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.
9. NIHR Moorfields Biomedical Research Centre, London, United Kingdom.
10. Makula Center, Südblick Eye Centers, Augsburg, Germany.
11. Medical Faculty, University of Bonn, Bonn, Germany.

Date: Published online October 10, 2025

Reference: Loughman J, Lingham G, Kaymak H, Lorenz K, Polling JR, Beck A, Carracedo G, Dahlmann-Noor AH, Müller PL, Flitcroft I; MyopiaX-1 Study Group. MyopiaX-1 Safety and Efficacy of a Novel Approach to Slow Juvenile Myopia Progression: A Multicenter, Randomized, Controlled Trial. Ophthalmol Sci. 2025 Oct 10;6(1):100973.

Link to open access paper

Light-based therapies for slowing myopia progression represent a novel area of investigation, driven by preclinical evidence that selective blue light stimulation of melanopsin-containing retinal ganglion cells may influence ocular growth via dopamine pathways. Melanopsin is a blue-sensitive photopigment concentrated in intrinsically photosensitive retinal ganglion cells. MyopiaX, a smartphone-based virtual reality application by Dopavision, is the first intervention designed to stimulate the optic nerve head (visual blind spot) to activate the melanopsin pathway with blue light. This proof-of-concept study evaluated its safety, tolerability, and early treatment effects in European children with myopia.

Key points were as follows.

• 101 treatment-naïve children aged 6–12 years in 11 centres across Germany, Ireland, the Netherlands, Portugal, Spain, and the United Kingdom were randomized in a 2:1 ratio to receive MyopiaX or Hoya MiYOSMART (DIMS) spectacles as an 'active control', and 81 were analyzed after 12 months of treatment.
• Over the first 6 months, MyopiaX use resulted in greater axial elongation than DIMS (0.14 mm vs. 0.08 mm), with similar refractive change in both groups (—0.18 D vs. —0.16 D).
• From months 6 to 12, children in the MyopiaX group added DIMS wear; axial elongation slowed to 0.04 mm, which was similar to the DIMS-only group.
• Compliance reduced over time, from 57% at 6 months to 26% at 12 months. Higher adherence to MyopiaX was associated with reduced axial elongation over 12 months.
• MyopiaX was well tolerated, with only mild transient side effects such as eye discomfort, headache, or dizziness.
• No structural or functional ocular safety concerns were observed.

This trial introduces MyopiaX as a novel therapy designed to deliver targeted blue light stimulation to the optic nerve head, aiming to modulate dopamine-driven pathways involved in ocular growth. While MyopiaX was not more effective than DIMS lenses over 6 months, the study provides valuable early insight into its potential utility. Axial elongation was greater in the MyopiaX group during monotherapy, but when DIMS was added in the second 6 months, elongation slowed to a rate similar to that of the DIMS-only group. While this would appear to indicate that MyopiaX didn’t provide a ‘boost’ effect to DIMS wear, it does indicate a likely similar effect in comparison to other monotherapies.

These initial results showed a relationship between efficacy and compliance, as well as a high safety and acceptance profile. Side effects such as eye strain, headache, and mild dizziness were infrequent, transient, and not unexpected with VR use.  The device’s gamified engagement and integrated monitoring capability is a unique opportunity to optimize compliance. While not ready for standalone use, MyopiaX may offer a promising complementary option in the future, especially for patients with low tolerance to drops or contact lenses.

Although this trial establishes a strong safety profile for MyopiaX, further research is needed to determine its standalone efficacy in myopia control. Axial elongation during the initial 6 months of monotherapy was greater than that seen with DIMS spectacles, raising questions about a dose-response relationship and required treatment frequency. The role of compliance is also an area for future research, given the relationship found here. Future studies could explore whether modifications to treatment delivery, such as enhanced gamification or altered session lengths, could improve engagement and clinical outcomes.

Additionally, it remains unclear whether targeting the optic nerve head with blue light provides any long-term advantage over more widespread retinal stimulation. The exact mechanism of action also warrants further investigation. Longer term trials could assess the durability of treatment effects. Finally, the role of MyopiaX as an adjunctive therapy in combination with optical treatments, and whether it is contraindicated with atropine (as is the case for repeated low-level red light therapy) could also be explored. 

Purpose: To investigate the safety, tolerability, and signals of effect of MyopiaX, a smartphone app that selectively delivers blue light to the optic nerve head to control myopia progression in children and adolescents.

Design: Multicenter, randomized, active-controlled, examiner-masked proof-of-concept clinical trial (ClinicalTrials.gov identifier NCT04967287).

Participants: Eligible children aged 6 to 12 years, with myopia of cycloplegic spherical equivalent refraction (SER) between -0.75 and -5.00 diopters (D) at baseline. Children were screened and enrolled between November 2021 and September 2023.

Methods: Children were randomly assigned in a 2:1 ratio to MyopiaX or active control. Participants were instructed to use MyopiaX for 10 minutes twice daily for the first 6 months and, during the second 6 months of the trial, also wear defocus incorporated multiple segments (DIMS) myopia control spectacles. The active control group wore DIMS spectacles for the entire 12-month trial.

Main outcome measures: The primary outcome was change in axial length (AL) and change in SER at month 6. Clinical safety examinations and the frequency and severity of device-related adverse events (AEs) were analyzed for all participants who began treatment.

Results: Of the 124 randomized participants, 101 were enrolled under the 12-month active-control study design (MyopiaX: n = 66, DIMS: n = 35). After 6 months, the mean AL change from baseline in the MyopiaX (n = 50) and DIMS (n = 34) groups, respectively, was 0.14 ± 0.11 mm and 0.08 ± 0.09 mm. The 6-month change in SER was -0.18 ± 0.39 D in the MyopiaX group and -0.16 ± 0.41 D in DIMS participants. Among the 73 participants who used MyopiaX, including those randomized under the original study design (prior to introduction of an active control), there were 23 related AEs among the 16 participants (22%), including transient ocular discomfort and headache, all of which resolved without any need for treatment.

Conclusions: MyopiaX was safe and well tolerated over 12 months in treatment-naive children with myopia. This exploratory study provides the first clinical data on the impact of MyopiaX's selective blue light stimulation on myopia progression and ocular growth. This novel approach may offer a complementary therapeutic solution for the clinical management of progressive myopia.