SightGlass Vision Presents 24-Month Data Demonstrating Myopia Control Efficacy for Vision Spectacle Lenses

Spectacles that use SightGlass Vision Diffusion Optics Technology have demonstrated efficacy in slowing the progression of myopia in children,[1] based on 24-month interim data from its pivotal clinical trial data presented this week at ARVO 2022. 

"Two Year Effectiveness of a Novel Myopia Management Spectacle Lens with Full Time Wearers" (Rappon J, Neitz J, Neitz M , Chung C, Chalberg T) is a featured presentation at the annual conference, which is attended by thousands of the world’s most respected ophthalmology, optometry, and vision science researchers.

An analysis of full-time wearers—children ages 6-10 at initiation whose parents reported that they did not remove the study spectacles for near vision activities—showed statistically significant improvements between groups using Diffusion Optics Technologylenses and the control. Axial length exhibited a 0.21 mm difference, and the spherical equivalent refraction difference was 0.52 D. 

Study investigators enrolled, randomized, and dispensed the lenses to 256 eligible children across 14 clinical trial sites in the United States and Canada—a geographical distinction compared to most other myopia-related spectacle lens studies. At the time of enrollment, subjects were 6 to 10 years old having myopia between -0.75 D and -4.50 D. The CYPRESS trial is now in its third year.

With a mean age of 8.1 years at screening, the CYPRESS cohort is younger than children in other well-known myopia management studies.[2]^[3][4] Given the higher likelihood of spectacles-based interventions for younger children, this study parameter should help build confidence in prescribers and families alike. Additional analysis of younger wearers will be presented at NCC 2022 this June. 

Spectacle lenses using patent-protected SightGlass Vision Diffusion Optics Technologyincorporate thousands of micro-dots that softly scatter light to reduce contrast on the retina—a method intended to reduce myopia progression in children.

“With their unique mechanism of action, Diffusion Optics Technology spectacle lenses represent a promising new approach to myopia control,” said Andrew Sedgwick, CEO of SightGlass Vision. “We’re enthusiastic about sharing more detail from the two-year interim results, which will further support our development efforts and ongoing commercialization activities in select markets.”

The last several decades have seen a steady rise in the prevalence of myopia worldwide, notably under the effect of lifestyle changes. Today affecting 2.6 billion people globally, it is estimated that nearly 5 billion people—half the world’s population—will be myopic by 2050.[5] Myopia is the leading cause of visual impairment in children and, over time, may contribute to an increased risk of developing permanent vision impairment, including macular degeneration, retinal detachment, cataract and glaucoma, and blindness associated with high myopia.[6]

References

[1] Spectacles with SightGlass Vision Diffusion Optics Technology™ are not approved for sale within the United States.

[2] GwiazdaJ, Hyman L, Hussein M, et al. A Randomized Clinical Trial of Progressive Addition Lenses versus Single Vision Lenses on the Progression of Myopia in Children. Invest OphthalmolVis Sci. 2003;44(4):1492.

[3] Walline JJ, GaumeGiannoni A, Sinnott LT, et al. A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods. Optometry and Vision Science. 2017;94(9):856-866.

[4] Yam JC, Jiang Y, Tang SM, et al. Low-Concentration Atropine for Myopia Progression (LAMP) Study. Ophthalmology. 2019;126(1):113-124.

[5] Holden et al. Global Prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016. 123(5):1036-42

[6] Tideman JW et al. Association of axial length with risk of uncorrectable visual impairment for Europeans with myopia. JAMA Ophthalmol. 2016;134:1355-1363