International Myopia Institute (IMI) Myopia Control .

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International Myopia Institute (IMI) Myopia Control Reports Overview andIntroductionJames S. Wolffsohn, FCOptom PhDOphthalmic Research Group, Aston University, Birmingham, UKDaniel Ian Flitcroft MB.BS. D.PhilChildren’s University Hospital, University College Dublin and Dublin Institute of Technology, IrelandKate L Gifford, BAppSc(Optom), PhDPrivate Practice and Queensland University of Technology, AustraliaMonica Jong BOptom, PhDBrien Holden Vision Institute and School of Optometry and Vision Science, University of New South Wales,Sydney, NSW, Australia.Lyndon Jones FCOptom, PhD, DScCentre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University ofWaterloo, Waterloo, Canada.Caroline C.W. Klaver MD, PhDDepartment of Ophthalmology, Radboud University Medical Center, Nijmegen, The NetherlandsNicola S. Logan, MCOptom PhDOphthalmic Research Group, Aston University, Birmingham, UKKovin Naidoo OD, PhDAfrican Vision Research Institute, Univ. of KwaZulu-Natal, Durban, South AfricaSerge Resnikoff MD, PhDBrien Holden Vision Institute and School of Optometry and Vision Science, University of New South Wales,Sydney, NSW, Australia.Padmaja Sankaridurg BOptom, PhDBrien Holden Vision Institute and School of Optometry and Vision Science, University of New South Wales,Sydney, NSW, AustraliaEarl L. Smith III, OD, PhDCollege of Optometry, University of Houston, Houston, TX, USADavid Troilo, PhDSUNY College of Optometry, State University of New York, New York, NY, USAChristine F. Wildsoet DipAppSci (Optom), BSci (Hons Pharm), PhDBerkeley Myopia Research Group, School of Optometry & Vision Science Program, University of CaliforniaBerkeley, Berkeley, CA, USAKeywords: myopia control; myopic progression; clinical guidelines; definition;interventions1

WORD COUNT: 9,296Figures and Tables: 3 of eachScientific section: CLCorresponding Author:James S. WolffsohnLife and Health Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET, United KingdomEmail: j.s.w.wolffsohn@aston.ac.ukPhone: 44 1212044140Grant support: International Myopia InstituteCommercial Relationships: NoneAbstractWith the growing prevalence of myopia, already at epidemic levels in some countries,there is an urgent need for new management approaches. However, with the increasingnumber of research publications on the topic of myopia control, there is also a clearnecessity for agreement and guidance on key issues, including on how myopia shouldbe defined and how interventions, validated by well conducted clinical trials, should beappropriately and ethically applied. The International Myopia Institute reports the criticalreview and synthesis of the research evidence to-date, from animal models, genetics,clinical studies and randomized controlled trials, by over 85 multidisciplinary experts inthe field, as the basis for the recommendations contained therein. As background to theneed for myopia control, the risk factors for myopia onset and progression are reviewed.The seven generated reports are summarized: Defining and Classifying Myopia;Experimental Models of Emmetropization and Myopia; Myopia Genetics; Interventionsfor Myopia Onset and Progression; Clinical Myopia Control Trials and Instrumentation;Industry Guidelines and Ethical Considerations for Myopia Control; Clinical MyopiaManagement Guidelines.2

1Previous guidance on myopia controlWhile eye care professionals have put forward views on how to slow edreviewtomakeclinicalrecommendations appears to have been in 2002, based on the only 10 randomisedcontrolled trials to have been conducted at that time. This report concluded that bifocalspectacle lenses and soft contact lenses were not recommended for slowing theprogression of myopia in children, nor was the routine use of atropine eye drops.1 Sincethat time, over 170 peer-reviewed articles on myopia control have been published,making it difficult for the clinician to keep abreast of the latest findings and how theyshould affect the optimum management of their patients. Few, if any, professionalbodies have issued documented guidance on the treatment of myopia (in contrast to thecorrection of the refractive error). While eye care practitioners from across the globeseem concerned about the increasing levels of myopia in their practices, especially inAsia, and report relatively high levels of activity in controlling myopia, the vast majoritystill prescribe single vision spectacles and contact lenses to their progressing myopes.2Hence, there is a need for evidence-based intervention strategies, informed by animalmodel and genetic studies, with agreement on how myopia should be defined, and,validated by well-designed and ethically applied clinical trials. The International MyopiaInstitute (IMI) reports represent the work of over 85 multidisciplinary experts in the field,who set out to critically review, synthesise and summarize the research evidence todate, (Table 1), and serve to inform both clinical practice and future research.Table 1:IMI report Subcommittee MembersIMI –Defining and Classifying MyopiaDaniel Ian Flitcroft MB.BS. D.PhilChildren’s University Hospital, University College Dublin and Dublin Institute of Technology,IrelandMingguang He MD PhDCentre for Eye Research Australia; Ophthalmology, Department of Surgery, University ofMelbourne, Melbourne, AustraliaJost B. Jonas MD3

Department of Ophthalmology, Medical Faculty Mannheim of the Ruprecht-Karis-UniversityHeidelberg, Mannheim, GermanyMonica Jong PhDBrien Holden Vision Institute and School of Optometry and Vision Science, University of NewSouth Wales, Sydney, NSW, Australia.Kovin Naidoo OD, PhDAfrican Vision Research Institute, Univ. of KwaZulu-Natal, Durban, South AfricaKyoko Ohno-Matsui, MD, PhDTokyo Medical and Dental University, Japan.Jugnoo Rahi, MB BS PhDInstitute of Child Health, University College London and Great Ormond Street Hospital forChildren, London, UKSerge Resnikoff MD, PhDBrien Holden Vision Institute and School of Optometry and Vision Science, University of NewSouth Wales, Sydney, NSW, Australia.Susan Vitale PhD, MHSNational Eye Institute, National Institutes of Health, Bethesda, MD, USALawrence Yannuzzi MDThe Vitreous, Retina, Macula Consultants of New York and the LuEsther T. Mertz RetinaResearch Center, Manhattan Eye, Ear, and Throat Hospital, New York, USA.IMI –Experimental Models of Emmetropization and MyopiaDavid Troilo, PhDSUNY College of Optometry, State University of New York, New York, NY, USAEarl L. Smith III, OD, PhDCollege of Optometry, University of Houston, Houston, TX, USADebora Nickla, PhDBiomedical Sciences and Disease, New England College of Optometry, Boston, MA, USARegan Ashby, PhDUniversity of Canberra, Health Research Institute, Canberra, AustraliaAndrei Tkatchenko, MD, PhDDepartment of Ophthalmology, Columbia University, New York, NY, USALisa A. Ostrin, OD, PhDCollege of Optometry, University of Houston, Houston, TX, USA4

Tim J. Gawne, PhDCollege of Optometry, University of Alabama Birmingham, Birmingham, AL, USAMachelle T. Pardue, PhDBiomedical Engineering, Georgia Tech College of Engineering, Atlanta, GA, USAJody A. Summers, PhDCollege of Medicine, University of Oklahoma, Oklahoma City, OK, USAChea-su Kee, BSc Optom, PhDSchool of Optometry, The Hong Kong Polytechnic University, Hong Kong, SAR, ChinaFalk Schroedl, MDDepartment of Ophthalmology and Anatomy, Paracelsus Medical University, Salzburg, AustriaSiegfried Wahl, PhDInstitute for Ophthalmic Research, University of Tuebingen, Zeiss Vision Science Laboratory,Tuebingen, GermanyLyndon Jones, PhD, DSc, FCOptomCentre for Ocular Research & Education (CORE), School of Optometry & Vision Science,University of Waterloo, Waterloo, Canada.IMI – Myopia GeneticsMilly S. Tedja MDDepartment of Ophthalmology / Epidemiology, Erasmus Medical Center, Rotterdam, theNetherlandsAnnechien E.G. Haarman MDDepartment of Ophthalmology / Epidemiology, Erasmus Medical Center, Rotterdam, theNetherlandsCREAM ConsortiumMagda A. Meester-Smoor PhDDepartment of Ophthalmology / Epidemiology, Erasmus Medical Center, Rotterdam, theNetherlandsJaakko Kaprio MD, PhDFaculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.David A. Mackey MD, PhD5

Department of Ophthalmology, Menzies Institute of Medical Research, University of Tasmania,Hobart, Tasmania, Australia.Jeremy Guggenheim MCOptom, PhDSchool of Optometry & Vision Sciences, Cardiff University, Cardiff, UK.Christopher J. Hammond MD, PhDSection of Academic Ophthalmology, School of Life Course Sciences, King's College London,London, UKVirginie J.M. Verhoeven MD, PhDDepartment of Ophthalmology / Epidemiology, Erasmus Medical Center, Rotterdam, theNetherlandsCaroline C.W. Klaver MD, PhDDepartment of Ophthalmology, Radboud University Medical Center, Nijmegen, The NetherlandsIMI – Interventions for Myopia Onset and ProgressionChristine F. Wildsoet DipAppSci (Optom), BSci (Hons Pharm), PhDBerkeley Myopia Research Group, School of Optometry & Vision Science Program, University ofCalifornia Berkeley, Berkeley, CA, USAAudrey Chia Wei Lin FRANZCO, PhDSingapore Eye Research Institute & Singapore National Eye Center, Singapore.Pauline Cho BOptom, PhDSchool of Optometry, The Hong Kong Polytechnic University, Hong KongJeremy A. Guggenheim MCOptom, PhDSchool of Optometry & Vision Sciences, Cardiff University, Cardiff, UKJan Roelof Polling BoHErasmus MC Dept. Ophthalmology, Rotterdam, NetherlandsScott Read BAppSci Optom (Hons), PhDSchool of Optometry & Vision Science and Institute of Health & Biomedical Innovation,Queensland University of Technology, Brisbane, AustraliaPadmaja Sankaridurg BOptom, PhDBrien Holden Vision Institute & School of Optometry and Vision Science, University of New SouthWales, Sydney, AustraliaSeang-Mei Saw MPH, PhD6

Saw Swee Hock School of Public Health, National University of Singapore, SingaporeKlaus Trier MDTrier Research Laboratories, Tingskiftevej 6, DK-2900 Hellerup, DenmarkJeff J. Walline OD, PhDThe Ohio State University College of Optometry, Columbus, OH, USAPei-Chang Wu MD, PhDDepartment of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital and Chang GungUniversity College of Medicine, Kaohsiung, TaiwanJames S. Wolffsohn, FCOptom PhDOphthalmic Research Group, Aston University, Birmingham, UKIMI - Clinical Myopia Control Trials and InstrumentationJames S. Wolffsohn, FCOptom PhDOphthalmic Research Group, Aston University, Birmingham, UKPete S. Kollbaum, OD, PhDIndiana University, School of Optometry, Bloomington, Indiana, USADavid A. Berntsen, OD PhDThe Ocular Surface Institute, College of Optometry, University of Houston,Houston, Texas, USADavid A. Atchison DScSchool of Optometry & Vision Science and Institute of Health & BiomedicalInnovation, Queensland University of Technology, AustraliaAlexandra Benavente MCOptom PhDSUNY College of Optometry, New York, NY, USA.Arthur Bradley, PhDIndiana University, School of Optometry, Bloomington, Indiana, USAHetal Buckhurst MCOptom PhDSchool of Health Professions, Peninsula Allied Health Centre, Plymouth University,Plymouth, UKMichael Collins Dip App Sc (Optom) PhDQueensland University of Technology, Australia7

Takashi Fujikado, MD, PhDDepartment of Applied Visual Science, Osaka University Graduate School ofMedicine, Osaka, Japan.Takahiro Hiraoka, MD, PhDDepartment of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki,Japan.Masakazu Hirota, MScDepartment of Applied Visual Science, Osaka University Graduate school ofMedicine, Osaka, Japan.Debbie Jones FCOptomSchool of Optometry & Vision Science, University of Waterloo, Waterloo, Ontario,CanadaNicola S. Logan, MCOptom PhDOphthalmic Research Group, Aston University, Birmingham, UKLinda Lundström PhDApplied Physics, KTH Royal Institute of Technology, SwedenScott A. Read BAppSci Optom, PhDSchool of Optometry & Vision Science and Institute of Health & BiomedicalInnovation, Queensland University of Technology, AustraliaHidemasa Torii MD, PhDDepartment of Ophthalmology, Keio University School of Medicine, Tokyo, JapanKovin Naidoo OD, PhDAfrican Vision Research Institute, University of KwaZulu-Natal, Durban, SouthAfricaIMI – Industry Guidelines and Ethical Considerations for Myopia ControlLyndon Jones, PhD, DSc, FCOptomCentre for Ocular Research & Education (CORE), School of Optometry & Vision Science,University of Waterloo, Waterloo, Canada.Björn Drobe, MSc, PhDEssilor R&D, Vision Sciences AMERA, Center of Innovation and Technology AMERA, Singapore,Singapore.8

José Manuel González-Méijome, OD, PhDClinical & Experimental Optometry Research Lab, Center of Physics (Optometry), School ofScience, University of Minho, Braga, Portugal.Lyle Gray PhD, BSc, Dip OptomDepartment of Vision Sciences, Glasgow Caledonian University, Glasgow, UK.Timo Kratzer, Dipl. PhysCarl Zeiss Vision International GmbH, Turnstraße 27, Aalen, 73430, Germany.Steve NewmanMenicon Company Limited, Nagoya, Japan.Jason J Nichols, OD, MPH, PhDUniversity of Alabama at Birmingham, School of Optometry, Birmingham, AL, USA.Arne Ohlendorf, PhDCarl Zeiss Vision International GmbH, Turnstraße 27, Aalen, 73430, Germany.Stephanie Ramdass, OD, MSVision Research Institute, Michigan College of Optometry, Ferris State University, Big Rapids,Michigan, USA.Jacinto Santodomingo-Rubido, MSc, PhDMenicon Company Limited, Nagoya, Japan.Katrina L Schmid, PhDSchool of Optometry and Vision Science, Institute of Health and Biomedical Innovation, Faculty ofHealth, Queensland University of Technology, Brisbane, Australia.Donald Tan, FRCSOphthalmology and Visual Sciences Academic Clinical Program, Duke-National University ofSingapore Medical School, Singapore Eye Research Institute, Singapore National Eye Centre.Kah-Ooi Tan, MBA, PhDBrien Holden Vision Institute, Sydney, Australia.Fuensanta A. Vera-Diaz, OD, PhDNew England College of Optometry, Boston MA USA.Yee-Ling Wong, BScEssilor R&D, Vision Sciences AMERA, Center of Innovation and Technology AMERA, Singapore,Singapore.Kate L Gifford, BAppSc(Optom), PhDPrivate Practice and Queensland University of Technology, AustraliaSerge Resnikoff MD, PhD9

Brien Holden Vision Institute, Sydney, Australia.IMI – Clinical Myopia Management GuidelinesKate L Gifford, BAppSc(Optom), PhDPrivate Practice and Queensland University of Technology, AustraliaKathryn Richdale, OD, PhDUniversity of Houston, USAPauline Kang, BOptom, PhDUniversity of New South Wales, AustraliaThomas A Aller, ODPrivate Practice and University of California, Berkeley, USACarly S Lam, BSc, PhDHong Kong Polytechnic University, Hong KongY Maria Liu, OD, PhDUniversity of California, Berkeley, USALangis Michaud, OD, MScUniversity of Montreal, CanadaJeroen Mulder, BOptom, MScUniversity of Applied Sciences Utrecht, NetherlandsJanis B Orr, BSc, PhDAston University, Birmingham, UKKathryn A Rose, PhDUniversity of Technology Sydney, AustraliaKathryn J Saunders, FCOptom, PhDUlster University, Londonderry, UKDirk Seidel, PhDGlasgow Caledonian University, Glasgow, UKJ Willem Tideman, MD, PhDErasmus Medical Centre, Rotterdam, NetherlandsPadmaja Sankaridurg BOptom, PhDBrien Holden Vision Institute & School of Optometry and Vision Science, University of New SouthWales, Sydney, Australia10

2The IMI Report Generation ProcessAs highlighted in the accompanying editorial, the foundation of the IMI was an outcomeof the WHO-associated global scientific meeting on Myopia, held at the Brien HoldenVision Institute in Sydney, Australia in 2015. As part of the IMI’s mission to addressidentified key issues related to myopia, they approached a group of experts to producetwo white papers in November 2015, one focused on Myopia Interventions (optical,pharmaceutical and behavioural / environmental) and the other on Definitions andClassification of Myopia (high myopia, pathologic myopia and myopic maculardegeneration). An IMI steering and advisory board were established also in November2015 at the American Academy of Ophthalmology meeting in Las Vegas to oversee theprocess. A separate initiative at a similar time, led by James Wolffsohn and NicolaLogan of Aston University (Birmingham, UK), approached leading experts in the field toestablish a steering committee to put together an evidence-based global consensus onmyopia control, in particular to inform clinicians, based on the well-established approachtaken by the Tear Film and Ocular Surface Society. The two groups agreed to bring theinitiatives together at a meeting at The Association for Research in Vision andOphthalmology (ARVO) in May 2016 in Seattle. It was agreed that Earl Smith andJames Wolffsohn would chair the initiative supported by the IMI. Monica Jong from theBrien Holden Vision Institute facilitated the entire process. In March 2017, the new whitepapers to accompany the original two had been agreed and potential chairsapproached.In developing this set of reports, the IMI has collaborated closely with the past andpresent organisers of The International Myopia Conference (IMC), an internationalevent that has been in existence since 1964 and is now a biennial event (Table 2). TheIMC is devoted to promoting all aspects of myopia research at the basic level through totranslational research and clinical myopia research thereby bringing together a widerange of disciplines. The attendance at the congress reflects the diversity of personsinvolved in myopia-related activities, including researchers, academics, practitioners,policy makers, industry representatives and students. The IMC started over 50 yearsago, however it was Dr. Sek Jin Chew in collaboration with Professor Josh Wallman11

who were instrumental in reviving the conference in 1990. The site hosting organizationand organizing committee change for each meeting, thus ensuring diversity at manylevels.Table 2:1st*Past International Myopia ConferencesNew York, USA (1964)2nd** Yokohama, Japan (1978)3rd** Copenhagen, Netherlands (1980)2nd* San Francisco, USA (1984)3rd*Rome, Italy (1986)4thSingapore (1990)5thToronto, Canada (1994)6thHakone, Japan (1996)7thTaipei, Taiwan (1998)8thBoston, Massachusetts, USA (2000)9thHong Kong, Guangzhou (2002)10thCambridge, UK (2004)11thSingapore (2006)12thCairns, Australia (2008)13thTübingen, Germany (2010)14thAsilomar, California, USA (2013)15thWenzhou, China (2015)16thBirmingham, UK (2017)*Organized by the Myopia International Research Foundation.**Independently organized by local organizing committees. (Not recognized by the Myopia InternationalResearch Foundation.)Chew and Wallman re-established the IMC meetings using local organizing committees beginning in1990, adopting the numbering based on the original MIRF sponsored meetings.Experts in the field (as identified by the IMI and IMC) were approached for expressionsof interest to contribute to one of the reports of their choice. An inclusive approach was12

adopted, while limiting the number of participants from any one research group toensure a balanced representation. Discussion between the chairs resulted in reportselection for each individual based on their expertise. The then IMI steering board(David Friedman; Mingguang He; Jonas Jost; Ohno-Matsui Kyoko; Kovin Naidoo(chair), Jason Nichols; Serge Resnikoff; Earl Smith; Hugh Taylor; Christine Wildsoet;James Wolffsohn; Tien Wong) and the chairs met at ARVO in May 2017 in Baltimore.The steering committee was responsible for developing the specific aims and mission,along with the strategy for these reports and agreed on the topics, conflict of interestpolicy, chairs and committee members. The chairs (Table 3) presented to a specialsession at the IMC in Birmingham, UK in September 2017 and the report committeemembership was expanded based on further interest and feedback. The reportcommittees also met to finalise their paper’s outline and to allocate the workloadimmediately after the meeting. Shortly after this meeting an agreement was put in placeto publish all the repo

The Ohio State University College of Optometry, Columbus, OH, USA Pei-Chang Wu MD, PhD Department of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan James S. Wolffsohn, FCOptom PhD Ophthalmic Research Group, Aston University, Birmingham, UK

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