At the beginning of October, CooperVision presented data from a clinical study on lenses with Diffusion Optics Technology from SightGlass Vision at the product launch in the Netherlands. Partner EssilorLuxottica, which will also launch the new myopia lenses, was also present.
EssilorLuxottica and CooperCompanies had reached an agreement in early February to form a joint venture to acquire SightGlass Vision, a US-based life sciences company involved in the development of innovative eyeglass lenses to reduce the progression of myopia in children.
CooperVision, part of CooperCompanies (San Ramon, California), released data in early October from a two-year clinical trial of its SightGlass Vision Business Diffusion Optics Technology, specifically designed to slow the progression of myopia in children (1). According to the study, after two years, children who wore their technology-equipped glasses all day without removing them for near activities had, on average, half a diopter less progression than those who wore the control glasses – a reduction of 59% (2).
In the Cypress clinical trial (3), 256 eligible children were enrolled, randomised and fitted with the lenses at 14 clinical trial sites in the United States and Canada. At the time of enrolment, subjects were 6 to 10 years old and had myopia between -0.75 dpt and -4.50 dpt.
After two years, 85% of the children wearing the new lenses had a myopia progression of less than one diopter (4). In addition, the study showed that 41% of the children wearing Diffusion Optics Technology lenses had no clinically significant progression of refractive error after two years, compared to only 17% in the control group (5).
Distance visual acuity was better than 6/6 (20/20) on average with Diffusion Optics Technology lenses at each visit and similar to single vision lenses (6) at all visits from dispensing to the 24-month visit. In the study, children wore both the test lenses and the standard single vision lenses for more than 12 hours per day on average over a 24-month period, suggesting that children quickly became accustomed to Diffusion Optics Technology (7). The Cypress study is now entering its third year.
Myopia lenses from the ophthalmologist
“Our team has focused exclusively on advancing medical science to not only correct children’s vision, but also slow the progression of myopia. By applying our Diffusion Optics Technology to eyeglass lenses, myopia management is easily integrated into eye care practices and can be easily incorporated into children’s daily lives,” said Joe Rappon, OD, MS, FAAO, Chief Medical Officer of SightGlass Vision (8).
Lenses that incorporate SightGlass Vision Diffusion Optics Technology already have a CE mark that slows the progression of myopia.
In recent decades, the prevalence of myopia has steadily increased worldwide, largely due to lifestyle changes. Today, myopia affects 2.6 billion people worldwide and it is estimated that by 2050, nearly 5 billion people, or half of the world’s population, will be myopic (9). Myopia is the leading cause of visual impairment in children and over time can contribute to an increased risk of developing permanent visual impairments, including macular degeneration, retinal detachment, cataract and glaucoma, as well as blindness associated with high myopia (10).
(1) Reductions in progression of spherical equivalent refraction and axial length from baseline over 24 months averaged 47% and 24%, respectively (p≤0.0041). (2) Compared to control spectacle lenses. Analysis based on parents’ responses to the question: “Does your child remove glasses for all near activities?” (n=51 test, n=62 control). For the entire study cohort, the reduction in baseline spherical equivalent refraction progression over 24 months averaged 47%. (3) Rappon J, Neitz J, Neitz M, Young G, Chalberg T. Cypress 12-month Results: Safety and Efficacy from a Pivotal Study of Novel Spectacle Lenses Designed to Reduce Myopia Progression. Optom Vis Sci. 2020;97:E-abstract 200036. (4) Compared to 65% of controls, p=0.0032 (n=74 test, n=87 control). (5) No clinically significant change in refractive error means myopia increased by less than 0.25 dpt from baseline as measured by cycloplegic autorefraction (p<0.0001). (6) Mean VA at high-contrast distance (logMAR) with Diffusion Optics Technology was -0.04, -0.06, -0.06, -0.08, -0.06 and -0.08 at baseline and at 30-day, 6-month, 12-month, 18-month and 24-month examinations, respectively. Mean visual acuity for high contrast distance (logMAR) with control lenses was -0.04, -0.06, -0.05, -0.06, -0.05, -0.06 at baseline, 30 days, 6 months, 12 months, 18 months and 24 months. (7) Lenses with Diffusion Optics Technology should be worn continuously for all activities except those specified in the warnings (at least 10 hours per day). (8) Measurements of pupil centre required. (9) Holden et al, – Global Prevalence of myopia and high myopia and temporal trends from 2000 through 2050. ophthalmology 2016. 123(5):1036-1042. (10) Tideman JW et al. Association of axial length with risk of incorrectable visual impairment for Europeans with myopia. JAMA Ophthalmol. 2016;134:1355-1363