MiyoSmart iQ: Retinal Stimulation for Myopia Control

LEARNING OBJECTIVES

On completion of this CPD activity, participants should:

1. Know the outcomes observed in randomised controlled trials for MiyoSmart iQ,
2. Understand the concepts behind defocus incorporated multiple segments (DIMS) technology, with triple enhanced design (TED), and
3. Understand the physiological responses to short-term wear of MiyoSmart iQ lenses.

MiyoSmart iQ (DIMS TED) is built upon one of the most extensively studied spectacle lens platforms in myopia management. Developed through a collaboration between HOYA Vision Care and The Hong Kong Polytechnic University (PolyU), MiyoSmart incorporates defocus incorporated multiple segments (DIMS) technology, the result of more than a decade of research into optical approaches for slowing childhood myopia progression.

The landmark two-year randomised controlled trial (RCT), published in 2019, demonstrated a 59% reduction in myopia progression and a 60% reduction in axial elongation compared with single-vision lenses.¹ Subsequent three-year and six-year follow-up studies confirmed that the treatment effect was sustained over time, with no evidence of rebound observed in long-term follow-up.² An eight-year follow-up clinical study demonstrated that the myopia control effect of MiyoSmart spectacle lenses was sustained in those children who wore them continuously for up to eight years, suggesting that long-term use provides continued benefits to improve myopia management outcomes.³

These outcomes helped establish MiyoSmart as one of the most evidence-based spectacle lens interventions available for myopia management.

However, clinical and research data indicate that treatment response can vary between children, reflecting the influence of multiple individual factors. These include age of myopia onset, level of myopia when starting intervention, and baseline progression rate, all of which may impact myopia control outcomes. Consistent with these observations, the development of MiyoSmart iQ focused on optimising the optical design to enhance the strength and consistency of the treatment effect across a broader paediatric population, as reflected in the high proportion of children showing minimal or no progression in the 12 month RCT.⁴

Addressing Variability in Response

Against this backdrop, HOYA’s research teams asked new questions: could the success of MiyoSmart be improved further? Could treatment efficacy become more consistent? Could younger children benefit?

The global rise in myopia is continuing at an alarming pace, with projections suggesting that nearly half of the world’s population could be affected by 2050.⁵ For eye care practitioners, the challenge has shifted from simple refractive correction to long-term risk reduction, recognising that progressive axial elongation during childhood is the key driver of future vision-threatening pathology. The urgency of early and effective intervention is widely acknowledged, yet variability in patient response continues to limit the effectiveness of current treatment strategies.

Spectacle lenses remain one of the most accessible and widely accepted approaches for paediatric myopia management, particularly in younger children.⁶ The introduction of defocus incorporated multiple segments (DIMS) technology marked a significant milestone, demonstrating that dual-focus spectacle lenses could deliver clinically meaningful reductions in myopia progression.

The development of MiyoSmart iQ represents a deliberate effort to move beyond established designs and address these limitations.

Rethinking Retinal Control of Eye Growth

The scientific understanding of myopia progression has evolved substantially in recent years, with increasing emphasis on the role of peripheral retinal signaling in regulating ocular growth.^7,8 While central vision remains essential for visual acuity, it is now well established that eye growth is controlled by local retinal mechanisms responding to optical defocus.

Within this framework, the near-peripheral retina has attracted particular attention. Research indicates that retinal regions within approximately six to 10° eccentricity exhibit heightened sensitivity to defocus signals and may exert a strong influence on axial elongation.⁹ This area has been described in the paper as a functional ‘sweet spot’, where myopic defocus can effectively modulate eye growth, even when central vision remains clear.

Experimental work in animal models has demonstrated that defocus applied to the macular region alone can influence refractive development, while electrophysiological studies in humans confirm differential retinal responses across eccentricity. These findings align with the concept that myopia progression is guided by cues from the near-peripheral retina rather than exclusively by foveal signals.

The biological mechanism underlying this response involves detection of myopic defocus, which triggers retinal signaling pathways that act through the choroid and sclera to slow axial elongation.¹⁰ Changes in choroidal thickness have emerged as a useful short-term biomarker of this process, with thickening associated with reduced ocular growth.

DIMS Technology with Triple Enhanced Design

The original MiyoSmart lens was based on DIMS technology, combining a central optical zone with a surrounding treatment area composed of multiple defocus segments in a honeycomb distribution. This approach allows for simultaneous clear central vision and peripheral myopic defocus and has been supported by a substantial body of clinical evidence.

MiyoSmart iQ addresses key challenges through a triple enhanced design (TED), incorporating three key modifications: adding defocus segments closer to the geometric centre, increasing defocus power, and expanding the treatment zone.

Activated

A key concept underpinning MiyoSmart iQ is the continuous activation of the near-peripheral retina during both distance and near viewing.

During distance vision, pupil size plays an important role. When pupil diameter exceeds approximately 4 mm, a greater proportion of light rays passing through the defocus segments reaches the near-peripheral retina, activating the intended treatment zone. This effect ensures that the defocusing signal is not limited to peripheral vision but is also present when looking straight through the centre of the glasses.

MiyoSmart iQ brings the defocus segments closer to the visual axis, resizing the central clear zone from 9.4 mm to 6.9 mm. Defocus segments closer to the centre of the spectacle lens are intended to continuously activate the near-peripheral retina, identified as the region most responsive to myopic defocus.

Powerful

Second, defocus segments in the treatment zone with a higher defocus power (increased from +3.50D to +4.50D) enable a stronger myopic defocus signal to the near-peripheral retina.

Extended

Third, the number of defocus segments has increased from 396 to 630, with a corresponding expansion of the treatment zone from 33 mm to 41 mm. This ensures extensive coverage of the child’s peripheral visual field with myopic defocus signal, even for larger frames. Taken together, these enhancements represent a shift toward a more physiologically targeted approach, aligning optical design with known retinal mechanisms.

A Structured Clinical Development Analysis

A notable aspect of MiyoSmart iQ is the structured evidence pathway used during development. Rather than relying solely on a single efficacy trial, the analysis evaluated visual performance, physiological response, and clinical efficacy in a sequential manner.

Phase I: Visual Performance and Adaptation. The first phase focused on visual performance and wearability. Clinical assessments demonstrated that visual acuity, accommodation, binocular vision, and overall adaptation remained comparable to both first-generation DIMS lenses and single-vision lenses.

Phase II: Physiological Response. The second phase investigated biological activity through changes in choroidal thickness. Choroidal thickening is increasingly recognised as a short-term biomarker associated with slowed axial elongation.

Early physiological responses provide important insights into the potential mechanism of action of MiyoSmart iQ. In controlled studies, the lens has been shown to induce a significant increase in choroidal thickness after a short period of wear, with changes of approximately 15.7 µm observed within two weeks.¹¹

The magnitude and speed of this response suggest that the enhanced design of MiyoSmart iQ can generate a strong biological signal early in treatment.

While choroidal changes are not themselves a clinical endpoint, they provide supportive evidence that the lens is effectively engaging the retinal mechanisms involved in eye growth regulation.

Phase III: Clinical Efficacy. The final phase consisted of a 12-month randomised controlled clinical trial involving 202 myopic children aged four to 12 years. The study compared MiyoSmart iQ with both single-vision lenses and first-generation DIMS lenses, evaluating changes in cycloplegic spherical equivalent refraction and axial length.

12-month Outcomes

The clinical performance of MiyoSmart iQ has been evaluated in a 12-month RTC involving 202 myopic children aged four to 12 years.⁴ The study compared the new lens design with both single-vision lenses and first-generation DIMS lenses, with cycloplegic spherical equivalent refraction and axial length as primary and secondary outcomes.

After 12 months, the results demonstrated a level of efficacy not previously reported for spectacle lenses. Children wearing MiyoSmart iQ showed, on average, no progression of myopia, with a mean change in spherical equivalent of +0.046D compared to -0.534D in the single vision control group.⁴

Axial length measurements further supported these findings. The MiyoSmart iQ group exhibited an average increase of only 0.075 mm, compared to 0.346 mm in the control group.⁴ This level of growth is comparable to that observed in emmetropic children, suggesting that the intervention may effectively normalise eye growth patterns.^12,13

From a clinical perspective, these data translate into a reduction in progression exceeding 100% for refractive error and approximately 94% for axial elongation.⁴ Importantly, around nine out of 10 children wearing the lens showed no clinically relevant myopia progression⁴ (changes in cycloplegic spherical equivalent refraction of ≥-0.50D) over the study period, indicating a high overall responder rate.

Age-Specific Considerations

Age remains one of the most important predictors of myopia progression, and the study provides valuable insights into age-dependent treatment effects.

In younger children aged four to six years, who typically exhibit faster progression, MiyoSmart iQ achieved a reduction in refractive progression of approximately 65% and a reduction in axial elongation of around 44%.4 Although lower than in older children, these outcomes are clinically meaningful and represent a significant advance, particularly given the limited evidence for spectacle-based interventions in this age group.

In children aged seven to 12 years, efficacy was substantially higher, with reductions exceeding 100% for refractive progression.4 In this group, axial growth was nearly halted, highlighting the potential for strong clinical impact when treatment is initiated during the early school years.

Visual Performance and Wearability

Maintaining visual performance is essential for the success of any spectacle-based intervention. Despite the increased defocus intensity, MiyoSmart iQ demonstrates visual performance comparable to MiyoSmart and single vision lenses.¹⁴

Clinical assessments have shown no clinically significant differences in visual acuity, accommodation, or binocular vision when compared to both DIMS and single-vision lenses.¹⁴ Subjective reports indicate a low frequency of visual symptoms, with most children adapting well to the lenses.

These findings are particularly relevant in paediatric populations, where comfort and ease of adaptation are critical for ensuring compliance. Consistent wear remains a key determinant of treatment success, and the ability to deliver high efficacy without compromising visual experience is a notable advantage.

Patient-centric improvements

MiyoSmart iQ not only strengthens the treatment performance, it also brings three patient‑centric improvements that enhance the everyday experience for young wearers.

Enhanced Coating

The first improvement is a new MiyoSmart iQ Spark coating, designed with children in mind and built for long‑term wear. It provides enhanced scratch resistance, ensuring effective myopia control as children play, learn, and grow.

Freeform Technology

The second improvement is the back‑side aspheric option with freeform technology, that reduces visual distortions and provides clearer vision in everyday life. These are not only spectacle lenses that perform well; they also look more appealing, especially for children with moderate to stronger prescriptions.

Extended Power Range

And finally, MiyoSmart iQ introduces an extended power range, from +2.00D to -13.00D in spherical equivalent, and up to -4.00D cylinder. This wider range allows eye care professionals to address a broader spectrum of prescriptions, including anisometropic cases.

Figure 6. Choroidal thickness was significantly increased after wearing MiyoSmart iQ for two weeks, by 15.69 ± 2.60 µm compared to the contralateral eyes with single vision spectacle lens as control, indicating the potential effectiveness of MiyoSmart iQ.

This article is sponsored by HOYA Vision Care.

Ulli Hentschel is the sales and marketing manager for HOYA Vision Care Australia and New Zealand. He has considerable experience overseeing national education and training initiatives for eye care professionals and has been an active voice in shaping eye care business operations across Australia and New Zealand.

References

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