Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial

Carly Siu Yin Lam, Wing Chun Tang, Dennis Yan-Yin Tse, Roger Pak Kin Lee, Rachel Ka Man Chun, Keigo Hasegawa, Hua Qi, Takashi Hatanaka, Chi Ho To, Carly Siu Yin Lam, Wing Chun Tang, Dennis Yan-Yin Tse, Roger Pak Kin Lee, Rachel Ka Man Chun, Keigo Hasegawa, Hua Qi, Takashi Hatanaka, Chi Ho To

Abstract

Aim: To determine if 'Defocus Incorporated Multiple Segments' (DIMS) spectacle lenses slow childhood myopia progression.

Methods: A 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8-13 years, with myopia between -1.00 and -5.00 D and astigmatism ≤1.50 D. Children were randomly assigned to wear DIMS (n=93) or single vision (SV) spectacle lenses (n=90). DIMS lens incorporated multiple segments with myopic defocus of +3.50 D. Refractive error (cycloplegic autorefraction) and axial length were measured at 6month intervals.

Results: 160 children completed the study, n=79 in the DIMS group and n=81 in the SV group. Average (SE) myopic progressions over 2 years were -0.41±0.06 D in the DIMS group and -0.85±0.08 D in the SV group. Mean (SE) axial elongation was 0.21±0.02 mm and 0.55±0.02 mm in the DIMS and SV groups, respectively. Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference -0.44±0.09 D, 95% CI -0.73 to -0.37, p<0.0001). Likewise, children in the DIMS group had less axial elongation by 62% than those in the SV group (mean difference 0.34±0.04 mm, 95% CI 0.22 to 0.37, p<0.0001). 21.5% children who wore DIMS lenses had no myopia progression over 2 years, but only 7.4% for those who wore SV lenses.

Conclusions: Daily wear of the DIMS lens significantly retarded myopia progression and axial elongation in myopic children. Our results demonstrated simultaneous clear vision with constant myopic defocus can slow myopia progression.

Trial registration number: NCT02206217.

Keywords: myopia; myopia control; myopic defocus; simultaneous vision; spectacle lens.

Conflict of interest statement

Competing interests: None. Patents titled ‘Spectacle Lens' in China (CN104678572 B) and in USA (US10268050 B2) were issued on 27 April 2018 and 23 April 2019 respectively.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The design of the Defocus Incorporated Multiple Segments (DIMS) spectacle lens.
Figure 2
Figure 2
A flow diagram of the study design. DIMS, Defocus Incorporated Multiple Segments spectacle lens; SV, single vision spectacle lens.
Figure 3
Figure 3
Model-adjusted mean and SE of myopia progression and axial length from baseline to 24 months. DIMS, Defocus Incorporated Multiple Segments; SER, spherical equivalent refraction.

References

    1. Morgan IG, Ohno-Matsui K, Saw S-M. Myopia. The Lancet 2012;379:1739–48.10.1016/S0140-6736(12)60272-4
    1. Holden BA, Fricke TR, Wilson DA, et al. . Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016;123:1036–42.10.1016/j.ophtha.2016.01.006
    1. Lam CS-Y, Lam C-H, Cheng SC-K, et al. . Prevalence of myopia among Hong Kong Chinese schoolchildren: changes over two decades. Ophthalmic Physiol Opt 2012;32:17–24.10.1111/j.1475-1313.2011.00886.x
    1. Vongphanit J, Mitchell P, Wang JJ. Prevalence and progression of myopic retinopathy in an older population. Ophthalmology 2002;109:704–11.10.1016/S0161-6420(01)01024-7
    1. Cheng SCK, Lam CSY, Yap MKH. Prevalence of myopia-related retinal changes among 12-18 year old Hong Kong Chinese high myopes. Ophthalmic Physiol Opt 2013;33:652–60.10.1111/opo.12082
    1. Xu L, Wang Y, Wang S, et al. . High myopia and glaucoma susceptibility the Beijing eye study. Ophthalmology 2007;114:216–20.10.1016/j.ophtha.2006.06.050
    1. Holden B, Sankaridurg P, Smith E, et al. . Myopia, an underrated global challenge to vision: Where the current data takes us on myopia control. Eye 2014;28:142–6.10.1038/eye.2013.256
    1. Fricke TR, Holden BA, Wilson DA, et al. . Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ 2012;90:728–38.10.2471/BLT.12.104034
    1. Huang J, Wen D, Wang Q, et al. . Efficacy comparison of 16 interventions for myopia control in children: a network meta-analysis. Ophthalmology 2016;123:697–708.10.1016/j.ophtha.2015.11.010
    1. Smith MJ, Walline JJ. Controlling myopia progression in children and adolescents. Adolesc Health Med Ther 2015;6:133–40.10.2147/AHMT.S55834
    1. Chua W-H, Balakrishnan V, Chan Y-H, et al. . Atropine for the treatment of childhood myopia. Ophthalmology 2006;113:2285–91.10.1016/j.ophtha.2006.05.062
    1. Chia A, Chua W-H, Cheung Y-B, et al. . Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology 2012;119:347–54.10.1016/j.ophtha.2011.07.031
    1. Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul Pharmacol Ther 2015;31:541–5.10.1089/jop.2015.0043
    1. Yam JC, Jiang Y, Tang SM, et al. . Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology 2019;126:113–24.10.1016/j.ophtha.2018.05.029
    1. Wallman J, Winawer J. Homeostasis of eye growth and the question of myopia. Neuron 2004;43:447–68.10.1016/j.neuron.2004.08.008
    1. Liu Y, Wildsoet C. The effect of two-zone concentric bifocal spectacle lenses on refractive error development and eye growth in young chicks. Invest Ophthalmol Vis Sci 2011;52:1078–86.10.1167/iovs.10-5716
    1. Tse DY, Lam CS, Guggenheim JA, et al. . Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci 2007;48:5352–9.10.1167/iovs.07-0383
    1. McFadden SA, Tse DY, Bowrey HE, et al. . Integration of defocus by dual power Fresnel lenses inhibits myopia in the mammalian eye. Invest Ophthalmol Vis Sci 2014;55:908–17.10.1167/iovs.13-11724
    1. Benavente-Perez A, Nour A, Troilo D. The effect of simultaneous negative and positive defocus on eye growth and development of refractive state in marmosets. Invest Ophthalmol Vis Sci 2012;53:6479–87.10.1167/iovs.12-9822
    1. Arumugam B, Hung L-F, To C-H, et al. . The effects of simultaneous dual focus lenses on refractive development in infant monkeys. Invest Ophthalmol Vis Sci 2014;55:7423–32.10.1167/iovs.14-14250
    1. Cho P, Cheung S-W. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci 2012;53:7077–85.10.1167/iovs.12-10565
    1. Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology 2011;118:1152–61.10.1016/j.ophtha.2010.10.035
    1. Lam CSY, Tang WC, Tse DY-Y, et al. . Defocus incorporated soft contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol 2014;98:40–5.10.1136/bjophthalmol-2013-303914
    1. Aller TA, Liu M, Wildsoet CF. Myopia control with bifocal contact lenses: a randomized clinical trial. Optom Vis Sci 2016;93:344–52.10.1097/OPX.0000000000000808
    1. Edwards MH, Li RW-H, Lam CS-Y, et al. . The Hong Kong progressive lens myopia control study: study design and main findings. Invest Ophthalmol Vis Sci 2002;43:2852–8.
    1. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:570–1.10.1136/bmj.313.7057.570
    1. Gwiazda J, 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 Ophthalmol Vis Sci 2003;44:1492–500.10.1167/iovs.02-0816
    1. Hasebe S, Ohtsuki H, Nonaka T, et al. . Effect of progressive addition lenses on myopia progression in Japanese children: a prospective, randomized, double-masked, crossover trial. Invest Ophthalmol Vis Sci 2008;49:2781–9.10.1167/iovs.07-0385
    1. Yang Z, Lan W, Ge J, et al. . The effectiveness of progressive addition lenses on the progression of myopia in Chinese children. Ophthalmic Physiol Opt 2009;29:41–8.10.1111/j.1475-1313.2008.00608.x
    1. Correction of Myopia Evaluation Trial 2 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. Invest Ophthalmol Vis Sci 2011;52:2749–57.10.1167/iovs.10-6631
    1. Berntsen DA, Sinnott LT, Mutti DO, et al. . A randomized trial using progressive addition lenses to evaluate theories of myopia progression in children with a high lag of accommodation. Invest Ophthalmol Vis Sci 2012;53:640–9.10.1167/iovs.11-7769
    1. Sankaridurg P, Donovan L, Varnas S, et al. . Spectacle lenses designed to reduce progression of myopia: 12-month results. Optom Vis Sci 2010;87:631–41.10.1097/OPX.0b013e3181ea19c7
    1. Sankaridurg P, Holden B, Smith E, et al. . Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci 2011;52:9362–7.10.1167/iovs.11-7260
    1. Cheng D, Woo GC, Drobe B, et al. . Effect of bifocal and prismatic bifocal spectacles on myopia progression in children: three-year results of a randomized clinical trial. JAMA Ophthalmol 2014;132:258–64.10.1001/jamaophthalmol.2013.7623
    1. Chamberlain P, Back A, Lazon P, et al. . 3 year effectiveness of a dual-focus 1 day soft contact lens for myopia control. Contact Lens and Anterior Eye 2018;41:S71–S72.10.1016/j.clae.2018.03.097
    1. Sng CCA, Lin X-Y, Gazzard G, et al. . Peripheral refraction and refractive error in Singapore Chinese children. Invest Ophthalmol Vis Sci 2011;52:1181–9.10.1167/iovs.10-5601

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