Dr. Altaz Shajani Dr. Sergiu Picioreanu Dr. Nav Sodhi Dr. Mahnia Madan 255 – 1233 Lynn Valley Road North Vancouver, BC, V7J 0A1 Informed Consent Resource for Myopia Management What is myopia? Myopia is blurry long-distance vision, often called ‘short-sightedness’ or ‘near-sightedness’. A person with myopia can typically see clearly up close – when reading a book or looking at a laptop screen – but words and objects look fuzzy on a whiteboard, on television, across the room, when looking outdoors or when driving. Why is myopia a concern? The rate of myopia is growing across the world, increasing from 22% of the world’s population in 2000 to 33% in 2020 – half of the world’s population expected to be myopic by 2050.1 Most myopia is caused by the eye length growing too quickly in childhood. The eyes are meant to grow from birth until the early teens and then cease, but in myopia the eyes grow too much and/or continue growing into the teenage years. Once a child becomes myopic, their vision typically deteriorates every 6-12 months, requiring a stronger and stronger prescription. Most myopic children tend to stabilize by the late teens and early 20’s.2 Excessive eye growth raises concern because even small amounts of stretching can lead to increased likelihood of vision threatening eye diseases in later life, such as myopic macular degeneration, retinal detachment, and cataract.3,4 Why manage myopia in children? Myopia progresses fastest in younger children, especially those under age 10.5 This means that the most important opportunity to slow eye growth is when children are younger. Myopia management aims to apply specific treatments to slow the excessive eye growth to a lesser rate. Experts agree that myopia management should be commenced for all children under age 12,6 and typically continue into the late teens.7 The short-term benefit of slowing myopia progression is that a child’s prescription will change less quickly, giving them clearer vision for longer between eye examinations. The long-term benefit is reducing the lifetime risk of eye disease and vision impairment. This risk increases as myopia does3 with the good news being that reducing the final level of myopia by only 1 diopter reduces the lifetime risk of myopic macular degeneration by 40% and the risk of vision impairment by 20%.8 Treatments for slowing myopia progression Standard, single-focus long distance spectacles or contact lenses do not slow down the progression of childhood myopia.8 Instead, specific types of spectacles, contact lenses and eye drops called atropine have been proven to slow myopia progression in children.6 The best option for your child will depend on their current prescription and other vision and eye health factors determined in their eye examination. Your eye care practitioner will discuss the options with you to determine the best option. Treatment options vary across the world due to availability, supply and regulatory reasons. It is important to note that no treatment can promise the ability to stop myopia progression in children, only to slow it down. Spectacles Standard single-focus spectacles do not slow the worsening of childhood myopia but specific designs do. Myopia controlling spectacles can both correct the blurred vision of myopia and work to slow down myopia progression. They are safe to wear and adaptation is typically easy, with the only side effects being related to the limitations spectacles pose for sport and active lifestyles. Contact lenses Standard single-focus contact lenses do not slow the worsening of childhood myopia but specific designs do. These specific designs can both correct the blurred vision of myopia and work to slow down myopia progression. The options include soft myopia controlling contact lenses and orthokeratology (Ortho-K). Risks and safety Contact lens wear increases the risk of eye infection compared to wearing spectacles, with the risks being: o 1 per 1,000 wearers per year for reusable soft contact lenses or overnight orthokeratology lenses9,10 o 1 per 5,000 wearers per year for daily disposable soft contact lenses9 With proper hygiene and maintenance procedures, this risk can be well managed – especially by avoiding any contact of water with contact lenses or accessories.11 Other side effects of contact lenses to control myopia can be temporary adaptation to the different experience of vision, which typically resolves in 1-2 weeks. Benefits There are many benefits to children wearing contact lenses: 1. Wearing contact lenses improves children’s self confidence in school and sport, and their satisfaction with their vision – as much as it does for teens12 2. Children aged 8-12 years appear to be safer contact lens wearers than teens and adults, with a lower risk of eye infection13 3. Children only take 15 minutes more to learn how to handle contact lenses than teens14 Ortho-K retainer lenses are worn overnight and removed upon waking, such that no spectacles or contact lenses are required for clear vision during the day. They can require more appointments for fitting than other types of myopia control treatment. Adaptation to the lens-on-eye feeling can take 1-2 weeks but shouldn’t affect sleep.17 There are significant benefits for water sports and active lifestyles, and since the contact lenses are only worn at home there is low risk of them being lost or broken during wear. Soft myopia controlling contact lenses are worn during waking hours. They may be daily disposable, or reusable for up to a month. They typically require more appointments for fitting than spectacles but less than Ortho-K. Adaptation to the lens-on-eye feeling typically occurs in a few days. There are benefits in safety with daily disposables being the safest modality, and the number of lenses retained meaning loss or breakage is less of a practical issue. Atropine eye drops Atropine eye drops in strong concentrations (typically 0.5% to 1%) are used to temporarily dilate the pupil of the eye and stop the focusing muscles working in a variety of clinical applications. Atropine eye drops for myopia control, though, are a low-concentration (0.01% to 0.05%) with much fewer such side effects. Spectacles or contact lenses are still needed to correct the blurred vision from myopia, as atropine only acts to slow myopia progression. Risks and safety The risks and side effects of atropine are as follows: • Potential side effects of increased sensitivity to light due to larger pupil size, which is typically resolved with light-sensitive glasses or sunglasses. One study found around a third of children requested these types of glasses, but this was the case even in the placebo (untreated) group.15 • Problems with close-up focusing, which is typically resolved with glasses providing a stronger power for reading. One study found this only occurred in 1-2% of children treated with low-concentration atropine.15 • Eye irritation or mild allergy, which can occur in 2-7%,15 although this can depend on the formulation of the atropine. Atropine can be toxic and even fatal to small children if it is ingested in high quantities by mouth, but high quantity absorption via the eye is unlikely.16 Medication safety in the home is extremely important. Benefits Atropine eye drops are typically used at night time, before sleep, so are only utilized in the home environment. They are also ideal if the effective spectacle or contact lens options for myopia control are not suitable or not available for your child. Informed Consent for Treatment I have had the available myopia management treatment options for my child explained to me, including which treatment may be best for my child and been offered the opportunity for discussion. As such I now understand that: - The risks and benefits for the various treatments as outlined above - Whilst these treatments are approved by the FDA and Health Canada for treatment and vision correction only some are approved specifically to slow the progression of myopia - The results for each child can vary and there is no guarantee on the effectiveness of any treatment for an individual - In some cases the evidence basis is for young children or specific prescription ranges, but older children may also require myopia control Fees for Tier 1 Fitting Category: Ortho-K Assessment and Consult: $300 Includes: -Myopia prescription measurement -Ocular health assessment for Ortho-K -Determination of Ortho-K candidacy -Consultation on Ortho-K risks and benefits Ortho-K Fitting package: $3,200 ($300 waived when signup within 30 days of the Ortho-K Assessment = $2,900) Includes: - All measurements for fitting of Ortho-K retainer lenses - Ortho-K retainer lenses (as many as required for optimal fit) - Dispensing of lenses - Insertion and removal training - Initial kit for cleaning and storage of lenses - All follow up examinations necessary for fitting of lens which normally takes 1-3 months - Disposable soft temporary contact lenses and fitting if required during the initial Ortho-K fitting process Ortho-K Management Program: $115 per month (subject to future change) - Starts once initial fit is completed (usually after 1 month) - The term is for the duration of the Ortho-K program for as long as the retainer lenses are worn, and for 6 months after cessation of wearing the retainer lenses (the washout). We recommend staying in the Ortho-K retainer lenses at least until the age of 21-25 years old while the eyes growing, however many of our patients continue wearing Ortho-K lenses throughout life. Ortho-K Management Program Includes: - Eye exams every 6 months to monitor the vision, prescription, ocular health and fit of the retainer lenses along with any follow up visits as required (Value $1000 annually) - New retainer lenses every 12 months (Value $800 annually) and refitting of lenses as needed (Value $1200) - Warranty 1 replacement pair due to breakage if required every 12 months (Value $800) - Washout examinations and management for 6 months after discontinuing Ortho-K to monitor ocular health, change in spectacle prescription, fitting of disposable soft contact lenses including 2 weeks’ worth of soft daily disposable contact lenses (Value $900) - After the washout period when prescription has stabilized, then options include spectacles, soft contact lenses or refractive surgery (depending on age) which are a separate fee. Child’s name ______________________________________________________ Parent’s name ______________________________________________________ Parent’s signature ______________________________________________________ Practitioner name ______________________________________________________ Date ______________________________________________________ For more scientifically-based, independent advice on childhood myopia and its management, go to mykidsvision.org. Suggested shorter reference list for parents 1. Holden et al 2016 https://pubmed.ncbi.nlm.nih.gov/26875007/ 2. COMET Group 2013 https://pubmed.ncbi.nlm.nih.gov/24159085/ 3. Flitcroft 2012 https://pubmed.ncbi.nlm.nih.gov/22772022/ 4. Tideman et al 2016 https://pubmed.ncbi.nlm.nih.gov/27768171/ 5. Chua et al 2016 https://pubmed.ncbi.nlm.nih.gov/27350183/ 6. Brennan et al 2020 https://pubmed.ncbi.nlm.nih.gov/33253901/ 7. Gifford et al 2019 https://pubmed.ncbi.nlm.nih.gov/30817832/ 8. Bullimore & Brennan 2019 https://pubmed.ncbi.nlm.nih.gov/31116165/ 9. Stapleton et al 2008 https://pubmed.ncbi.nlm.nih.gov/18538404/ 10. Bullimore et al 2013 https://pubmed.ncbi.nlm.nih.gov/23892491/ 11. Arshad et al 2019 https://pubmed.ncbi.nlm.nih.gov/30789440/ 12. Walline et al 2007a https://pubmed.ncbi.nlm.nih.gov/17993828/ 13. Bullimore 2017 https://pubmed.ncbi.nlm.nih.gov/28514244/ 14. Walline et al 2007b https://pubmed.ncbi.nlm.nih.gov/17873776/ 15. Yam et al 2019 https://pubmed.ncbi.nlm.nih.gov/30514630/ 16. North & Kelly 1987 https://pubmed.ncbi.nlm.nih.gov/2958765/ 17. Yang et al 2021 https://pubmed.ncbi.nlm.nih.gov/32674999/ Full Reference List 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. 2016 May;123(5):1036-42. 2. COMET Group. Myopia stabilization and associated factors among participants in the Correction of Myopia Evaluation Trial (COMET). Invest Ophthalmol Vis Sci. 2013 Dec 3;54(13):7871-84. 3. Flitcroft DI. The complex interactions of retinal, optical and environmental factors in myopia aetiology. Prog Retin Eye Res. 2012 Nov;31(6):622-60. 4. Tideman JW, Snabel MC, Tedja MS, van Rijn GA, Wong KT, Kuijpers RW, Vingerling JR, Hofman A, Buitendijk GH, Keunen JE, Boon CJ, Geerards AJ, Luyten GP, Verhoeven VJ, Klaver CC. Association of Axial Length With Risk of Uncorrectable Visual Impairment for Europeans With Myopia. JAMA Ophthalmol. 2016 Dec 1;134(12):1355-1363. 5. Chua SY, Sabanayagam C, Cheung YB, Chia A, Valenzuela RK, Tan D, Wong TY, Cheng CY, Saw SM. Age of onset of myopia predicts risk of high myopia in later childhood in myopic Singapore children. Ophthalmic Physiol Opt. 2016 Jul;36(4):388-94. 6. Brennan NA, Toubouti YM, Cheng X, Bullimore MA. Efficacy in myopia control. Prog Retin Eye Res. 2020 Nov 27:100923. doi: 10.1016/j.preteyeres.2020.100923. 7. Gifford KL, Richdale K, Kang P, Aller TA, Lam CS, Liu YM, Michaud L, Mulder J, Orr JB, Rose KA, Saunders KJ, Seidel D, Tideman JWL, Sankaridurg P. IMI - Clinical Management Guidelines Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M184-M203. doi: 10.1167/iovs.18-25977. 8. Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019 Jun;96(6):463-465. 9. Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JKG, Brian G, Holden BA. The Incidence of Contact Lens Related Microbial Keratitis in Australia. Ophthalmol. 2008;115:1655-1662. 10. Bullimore MA, Sinnott LT, Jones-Jordan LA. The risk of microbial keratitis with overnight corneal reshaping lenses. Optom Vis Sci. 2013;90:937-944. 11. Arshad M, Carnt N, Tan J, Ekkeshis I, Stapleton F. Water Exposure and the Risk of Contact Lens-Related Disease. Cornea. 2019 Jun;38(6):791-797. 12. Walline JJ, Gaume A, Jones LA, Rah MJ, Manny RE, Berntsen DA, Chitkara M, Kim A, Quinn N. Benefits of contact lens wear for children and teens. Eye Contact Lens. 2007;33(6 Pt 1):317-321. 13. Bullimore MA. The Safety of Soft Contact Lenses in Children. Optom Vis Sci. 2017;94(6):638-646. 14. Walline JJ, Jones LA, Rah MJ, Manny RE, Berntsen DA, Chitkara M, Gaume A, Kim A, Quinn N. Contact Lenses in Pediatrics (CLIP) Study: chair time and ocular health. Optom Vis Sci. 2007;84:896-902. 15. Yam JC, Jiang Y, Tang SM, Law AKP, Chan JJ, Wong E, Ko ST, Young AL, Tham CC, Chen LJ, Pang CP. 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 Jan;126(1):113-124. 16. North RV, Kelly ME. A review of the uses and adverse effects of topical administration of atropine. Ophthalmic Physiol Opt. 1987;7(2):109-14. 17. Yang B, Ma X, Liu L, Cho P. Vision-related quality of life of Chinese children undergoing orthokeratology treatment compared to single vision spectacles. Cont Lens Anterior Eye. 2021 Aug;44(4):101350.