See the future of myopia management

Transcription

1 See the future of myopia management

2 Contents Myopia: a global epidemic Introducing MiSight 1 day MiSight 1 day: the results (three years) 1 2 3

3 Myopia: A global epidemic

4 UK: Over the last 50 years, myopia has more than doubled 1 RESEARCH ARTICLE Six Year Refractive Change among White Children and Young Adults: Evidence for significant increase in myopia among white UK children Conclusion: The proportion of myopes in the UK has more than doubled over the last 50 years in children aged between years and children are becoming myopic at a younger age. 1. McCullough SJ, O Donoghue L, Saunders KJ (2016) Six Year Refractive Change among White Children and Young Adults: Evidence for Significant Increase in Myopia among White UK Children. PLoS ONE 11(1)

5 In 2010, 28% of the global population was myopic 1 1. Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S, Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050, Ophthalmology, May 2016 Volume 123, Issue 5, Pages

6 By 2050, 50% of the global population is predicted to be myopic 1 1. Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S, Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050, Ophthalmology, May 2016 Volume 123, Issue 5, Pages

7 All myopes have potential for significant ocular health risk 1 Prescription Retinal detachment Myopic maculopathy Do nothing x 40x Reduce by 50% x 10x Reduce by 75% x 2x 1. Flitcroft DI. The complex interactions of retinal, optical and environmental factors in myopia aetiology. Prog Retin Eye Res. 2012;31:

8 All myopes have potential for significant ocular health risk 1 Prescription Retinal detachment Myopic maculopathy Do nothing x 40x A 50% control effect would lead to over 90% reduction in the frequency of Reduce by 50% x 10x myopia greater than Reduce by 75% x 2x 1. Flitcroft DI. The complex interactions of retinal, optical and environmental factors in myopia aetiology. Prog Retin Eye Res. 2012;31:

9 Introducing MiSight 1 day

10 Development of MiSight 1 day Transferred to Proclear 1 Day material back in 2009 Design was evolved to suit the Proclear material and optimised profile across the power range CE approved

11 Overview of MiSight 1 day with ActivControl technology Soft 1-day lens Optical zone with ActivControl technology Four optical zones - Two correction zones (refractive correction) - Two treatment zones (+2.00D: myopic defocus) Myopic defocus controls axial elongation (and therefore refractive error) as the treatment zone image focus is in front of the retina, not behind treatment zones creating myopic defocus correction zones

12 How ActivControl technology works? Correction zones ensure myopia is fully corrected in all gaze positions and consistently across the power range Treatment zones ensure consistent myopic defocus in all gaze positions Light Focal point treatment zones creating myopic defocus correction zones Artist s impression

13 Long term clinical study 3 year parallel-group, randomised, double-masked, multi-centre study extended to five years Subjects split into two groups: Control group Proclear 1 day Test group MiSight 1 day Four sites around the world Canada, UK, Portugal, Singapore Two year data completed in mid 2016 and presented at AAO with decision made to commercialise the product Three year data presented BCLA conference, June 2017

14 MiSight 1 day: the three year results

15 Refractive error change: MiSight 1 day reduces the rate of myopia progression by 59% over a three-year period 1 1. Chamberlain, P et al. CLINICAL EVALUATION OF A DUALFOCUS MYOPIA CONTROL 1 DAY SOFT CONTACT LENS - 3-YEAR RESULTS, BCLA meeting June 2017

16 Axial length change: MiSight 1 day wearers had 52% less growth over a three-year period 1 Changes in refractive error are highly correlated with changes in eyes' axial lengths 1. Chamberlain, P et al. CLINICAL EVALUATION OF A DUALFOCUS MYOPIA CONTROL 1 DAY SOFT CONTACT LENS - 3-YEAR RESULTS, BCLA meeting June 2017

17 41% of children progressed by -0.25D or less over three years % Subjects 80% 60% Proclear 1 day MiSight 1 day 73% 40% 20% 41% 33% 0% 4% % in SERE or less % -0.75D or more progression 1. Chamberlain, P et al. CLINICAL EVALUATION OF A DUALFOCUS MYOPIA CONTROL 1 DAY SOFT CONTACT LENS - 3-YEAR RESULTS, BCLA meeting June 2017

18 Children are able to handle their lenses independently 1 After the first week of wear, parents had minimal involvement with lens handling How often do you insert your child's CLs? Control + MiSight 1 week Control + MiSight 1 month Control + MiSight 12 months % 50% 60% 70% 80% 90% 100% How often do you remove your child's CLs? Control + MiSight 1 week Control + MiSight 1 month Control + MiSight 12 months % 50% 60% 70% 80% 90% 100% < 1 per month 1-2 per month 4-5 per month 5-10 per month N= Chamberlain, P et al. CLINICAL EVALUATION OF A DUALFOCUS MYOPIA CONTROL 1 DAY SOFT CONTACT LENS - 2-YEAR RESULTS, AAO meeting November 2016

19 Children prefer wearing contact lenses to their glasses 1 Children were far more satisfied with their contact lenses than their spectacles. Satisfaction of children wearing MiSight 1 day was similar to the spherical lens. How do you like wearing CLs? 1 week Control MiSight month Control MiSight months Control MiSight % 40% 50% 60% 70% 80% 90% 100% I like them best I kind of like them Neither I don t like them N=59-68 per group 1. Chamberlain, P et al. CLINICAL EVALUATION OF A DUALFOCUS MYOPIA CONTROL 1 DAY SOFT CONTACT LENS - 2-YEAR RESULTS, AAO meeting November 2016

20 Parents are at ease with their children wearing contact lenses 1 Parents concerns with their child wearing contact lenses was significantly reduced after witnessing the first four weeks of wear. How at ease are you with the prospect of your child wearing CLs? 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Prior to the study +1 week +1 month +12 months Extremely uncomfortable Somewhat uncomfortable Neither Somewhat at ease Extremely at ease N= Chamberlain, P et al. CLINICAL EVALUATION OF A DUALFOCUS MYOPIA CONTROL 1 DAY SOFT CONTACT LENS - 2-YEAR RESULTS, AAO meeting November 2016

21 Other Palpebral Roughness Palpebral Hyperaemia Corneal Vascularisation Bulbar Hyperaemia Limbal Hyperaemia Clinical observations are minimal* 3 Year 2 Year 1 Year Baseline 3 Year 2 Year 1 Year Baseline 3 Year 2 Year 1 Year Baseline 3 Year 2 Year 1 Year Baseline 3 Year 2 Year 1 Year Baseline 3 Year 2 Year 1 Year Baseline 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% % of eyes Efron grade *data from both test and control group at baseline 1,2, and 3 year mark. Lenses worn for ~13 hrs per day, 6.5 days per week across both groups

22 MiSight 1 day fitting guide STEP 1 Optimise the spectacle prescription With the most up-to-date refraction* in the trial frame, confirm optimal prescription using the binocular balancing technique STEP 2 Select and evaluate MiSight 1 day Select initial MiSight 1 day lens from best vision sphere**. Adjust for vertex distance. Record vision Assess fit Increase minus in 0.25D steps only if it significantly improves distance vision Reduce minus on 0.25D steps, provided there is no decrease in visual acuity and no subjective visual impact STEP 3 Recommendations and follow-up Recommended minimum wearing time 6+ days per week, 10+ hours per day Schedule a follow-up visit for one week Assess handling technique Confirm adaptation to vision Top tip: Ghosting and haloes are normal at first and demonstrate a normal visual sensation of this therapy *A cycloplegic refraction can be a helpful baseline reference before an initial fitting of MiSight 1 day **For optimum results, ensure that the vertex-corrected cylinder is 0.75D

23 MiSight 1 day specifications Material Omafilcon A Water content 60% Base curve (mm) 8.7 Diameter (mm) 14.2 Sphere power Optical design to (0.25 steps) ActivControl Technology Dk/t (at -3.00D) 28 Pack Size 30 Replacement schedule Daily disposable

24 Summary Myopia is reaching epidemic proportions, with 50% of the global population set to become myopic by 2050 Current myopia management options have limitations. We need an effective, easy-to-fit product, available to all eye care professionals that is easy to wear for children MiSight 1 day is the first daily disposable soft contact lens specifically designed to address these needs ActivControl technology High efficacy over three years Easy to wear

25 Bibliography Aller TA (2006) Results of a one-year prospective clinical trial (CONTROL) of the use of bifocal soft contact lenses to control myopia progression. Ophthalmic and Physiological Optics 26(1): 8-9. Anstice NS and Phillips JR (2011) Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology 118(6): Cedrone C, Nucci C, Scuderi G, Ricci F, Cerulli A, Culasso F. Prevalence of blindness and low vision in an Italian population: a comparison with other European studies. Eye. 2005;20: Chamberlain, P et al. (2016) Clinical evaluation of a dualfocus myopia control 1 day soft contact lens - 2-year results, AAO meeting November 2016 Cheng, D., Woo, G. C. and Schmid, K. L. (2011), Bifocal lens control of myopic progression in children. Clinical and Experimental Optometry, 94: doi: /j x Cho P, Cheung SW, and Edwards M (2005) The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res 30(1): Chung K, Mohidin N, O Leary DJ. (2002) Undercorrection of myopia enhances rather than inhibits myopia progression. Vision Res. Oct;42(22): Edwards MH, Li RW, Lam CS, Lew JK, Yu BS. The Hong Kong progressive lens myopia control study: study design and main findings. Invest Ophthalmol Vis Sci. 2002;43(9): Evans JR, Fletcher AE, Wormald RPL. Causes of visual impairment in people aged 75 years and older in Britain: an add-on study to the MRC Trial of Assessment and Management of Older People in the Community. The British Journal of Ophthalmology. 2004;88(3): doi: /bjo Fulk GW, Cyert LA, and Parker DE (2000) A randomized trial of the effect of single-vision vs. bifocal lenses on myopia progression in children with esophoria. Optom Vis Sci 77(8): Gifford P. Gifford, K. The Future of Myopia Control Contact Lenses. Optometry and Vision Science. Vol. 93 April 2016 Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, and Scheiman M (2003) A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci 44(4): Hasebe S, Nonaka F, Nakatsuka C, and Ohtsuki H (2005) Myopia control trial with progressive addition lenses in Japanese schoolchildren: baseline measures of refraction, accommodation, and heterophoria. Jpn J Ophthalmol 49(1): Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S, Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050, Ophthalmology, May 2016 Volume 123, Issue 5, Pages Hsu WM, Cheng, CY, Liu JH, Tsai SY, Chou P. (2004) Prevalence and causes of visual impairment in an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthamology. Jan;111(1):62-9. Iwase A, Araie M, Tomidokoro A, Yamamoto T, Shimizu H, Kitazawa Y; Tajimi Study Group. Prevalence and causes of low vision and blindness in a Japanese adult population: the Tajimi Study. Ophthalmology. 2006;113:

26 Bibliography Jing Sun et al. Prevalence of myopia in Chinese students. Invest. Ophthalmol. Vis. Sci.2012; 53(12): Kakita T, Hiraoka T, and Oshika T (2011) Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci 52(5): McCullough SJ, O Donoghue L, Saunders KJ (2016) Six Year Refractive Change among White Children and Young Adults: Evidence for Significant Increase in Myopia among White UK Children. PLoS ONE 11(1) McCullough S, Saunders K. Childhood Myopia in the 21 st Century. Optometry Today. June Sankaridurg P, Donovan L, Varnas S, Ho A, Chen X, Martinez A, Fisher S, Lin Z, Smith EL, 3rd, Ge J, and Holden B (2010) Spectacle lenses designed to reduce progression of myopia: 12-month results. Optom Vis Sci 87(9): Sankaridurg P, Holden B, Smith E, 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, and Ge J (2011) Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci 52(13): Walline J, Jones-Jordan LA, Greiner KL, and McVey M (2011) The effects of soft bifocal contact lenses on myopia progression in children. Optometry and Vision Science 88: E-Abstract: Walline JJ, Jones LA, and Sinnott LT (2009) Corneal reshaping and myopia progression. Br J Ophthalmol 93(9): Wolffsohn JS. Review of current myopia management practice across the globe: the BCLA survey. Cont Lens Anterior Eye 2015:conference presentation Yang Z, Lan W, Ge J, Liu W, Chen X, Chen L, and Yu M (2009) The effectiveness of progressive addition lenses on the progression of myopia in Chinese children. Ophthalmic and Physiological Optics 29(1): Yoshida T et al. Myopic choroidal neovascularization: a 10-year follow-up. Ophthalmology Jul;110(7): CLEERE Study Group Early Childhood Refractive Error and Parental History of Myopia as Predictors of Myopia. Invest Ophthalmol Vis Sci Jan; 51(1): Correction of Myopia Evaluation Trial 2 (COMET2) Study Group for the Pediatric Eye Disease Investigator Group. Progressive-Addition Lenses versus Single-Vision Lenses for Slowing Progression of Myopia in Children with High Accommodative Lag and Near Esophoria. Investigative Ophthalmology & Visual Science. 2011;52(5): doi: /iovs