November 1, 2024
By Tina Douroudian, OD
Children need our best available treatment options now — allowing their myopia to progress while we do more research isn’t good enough.
Every year, more children become myopic at younger ages, making myopia management increasingly important. Three treatments are now available in the U.S.: low-dose atropine, orthokeratology, and dual focus and EDOF soft contact lenses (next-generation spectacles are not currently available in the U.S.). But what should clinicians do when a patient needs more than one of them? What are the protocols for combination therapy? And how do we determine not only who should receive combination therapy but also when?
I lead myopia management at Arlington Loudoun Pediatric Ophthalmology. This busy practice presents me with a variety of challenging cases — for example, a 5-year-old increasing 1.00D every three months, or infantile myopia (do our known myopia control methods even work for them?), or children whose eyes just don’t respond the way we expect them to. As a result, I’ve sought to determine the best practices for combination therapy.
Defining Combination Therapies
Here is what I categorize as dual or combination therapies:
- Low-dose atropine and dual focus and EDOF soft contact lenses
- Low-dose atropine and orthokeratology
- Low-dose atropine and myopia control spectacles (obtained outside the U.S.)
I advise all patients to make lifestyle adjustments such as reduced screen time, appropriate near-work hygiene, and increased outdoor time, so I do not consider these additional treatments. To me, these changes are akin to drinking more water — everyone should be doing it.
Adopting a Protocol for Combination Therapy
With those considerations in mind, here is my protocol for dual treatment:
- At an initial office visit, we measure the axial length of patients at risk for developing myopia or those who already have it. We determine the patient’s axial length percentile, which helps me evaluate their level of risk for highly progressive myopia. Patients above the 95th percentile are more likely to require combination therapy, though we’ll use additional information to determine whether they’ll ultimately receive it.
- Patients with other important risk factors — such as having a sibling or parents with highly progressive myopia or a pattern of steep myopia increases in a short period of time — will also alert me to the need for possible combination therapy.
- I rarely start with combination therapy unless I have clinical evidence that a patient’s myopia is highly progressive and unlikely to be managed well with monotherapy.
- After this initial visit, we will start the preferred treatment option and follow up quarterly. If it becomes apparent in the first three to six months with good patient compliance that the treatment is insufficient at controlling the patient’s myopia, as evidenced by a larger-than-expected increase in axial length and/or a significant change in cycloplegic refraction, then we discuss dual treatment.
What Are Normal Changes in Axial Length?
We know that just like the rest of their bodies, children’s eyes are meant to grow — myopia is simply a problem of their eyes growing too quickly. Normal eye growth, or physiological growth, is about 0.1-0.2mm annually, with younger kids growing faster. If a child’s eyes are growing at the physiological growth rate, this should correspond to minimal to no myopic increases. Suppose a child’s eyes are technically changing at that rate, but they still have a significant increase in myopia. In that case, that likely indicates poor myopia control and a need for combination treatment.
For patients who are unable or unwilling to select an optical form of myopia management, I have also had some success with adding two drops of low-dose atropine spaced five minutes apart. (See below for “Which Concentration of Atropine is Best?”)
What Do the Studies Tell Us?
Most studies on myopia management focus on monotherapy. However, the field of myopia management has exploded over the last several years, and there is growing evidence that combination therapies can slow down progressive cases. Likely, the slower rate of studies of combination treatments is linked to a lack of established protocols for identifying who is at the highest risk of needing combination treatments and, therefore, who should — and shouldn’t — be enrolled in clinical trials. Similarly, few trials include patients with significant amounts of astigmatism despite the enormous clinical need for meaningful studies involving them.
These studies1-4 demonstrated an improved effect on axial elongation with the combination of orthokeratology and 0.01% atropine. Long-term data are still needed to identify if the effect on axial elongation is maintained beyond two years and after discontinuation of treatment. However, for patients who responded poorly to orthokeratology, Chen et al.5 determined in their three-year study that adding atropine had no additional benefit.
The studies reviewing the combination of soft multifocal contact lenses and atropine showed fewer promising results.6 But increasing the dose from 0.01% may be of use since we know in other trials, 0.01% atropine was no better than a placebo at slowing down myopia.7 Anecdotally, the use of 0.025% or 0.05% atropine in combination has been successful, with some of my trickier cases requiring dual therapy.
More studies, especially on American children, are needed when evaluating the combination approach for myopia control spectacle lenses. Two studies demonstrated additive effects of atropine 0.01% with Defocus Incorporated Multiple Segments (DIMS)-style myopia control spectacles, although different levels of efficacy were reported. These trials recruited European and Asian populations, respectively.8,9
Which Concentration of Atropine is Best?
Based on the available research, I generally advocate for a concentration of atropine that is higher than 0.01% for mono or combination therapy. When using atropine as a monotherapy, I almost exclusively select 0.05%. However, when used in combination regimens, there is reason to believe a lower concentration of atropine can still be effective, so I will typically start with 0.025% if atropine is the secondary therapy.
In conclusion, myopia management is a rapidly expanding field of research with a lot of nuance and clinical considerations. We have a lot of work to do when designing the perfect treatment protocols for myopia management, but the patients in our chairs can’t wait for “perfect.” These children need our best available treatment options now. Allowing their myopia to progress while we do more research isn’t good enough.
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Dr. Tina Douroudian graduated from the State University of New York College of Optometry. She was recently nominated by her peers to represent Virginia as a Myopia Collective Change Agent. She sits on the Board of Trustees for the Northern Virginia Optometric Society. Dr. Douroudian was the head of a pediatric department of a hospital-based ophthalmology clinic in Brooklyn, NY, where she worked with ophthalmologists of different subspecialties, and she was the clinical educator and supervisor for SUNY Optometry fourth year student interns. Dr. Douroudian also worked with a pediatric mobile clinic in New York City where she provided no-cost eye exams and glasses for tens of thousands of children throughout NYC’s five boroughs. She lives in Sterling, Virginia, with her husband and two children. You can follow her on Instagram at @idoctortina. |
References
- Kinoshita N, Konno Y, Hamada N, Kanda Y, Shimmura-Tomita M, Kakehashi A. Additive effects of orthokeratology and atropine 0.01% ophthalmic solution in slowing axial elongation in children with myopia: first year results. Jpn J Ophthalmol. 2018;62(5):544-553. doi:10.1007/s10384-018-0608-3
- Yu S, Du L, Ji N, et al. Combination of orthokeratology lens with 0.01% atropine in slowing axial elongation in children with myopia: a randomized double-blinded clinical trial. BMC Ophthalmol. 2022;22(1):438. doi:10.1186/s12886-022-02635-0
- Tan Q, Ng AL, Cheng GP, Woo VC, Cho P. Combined 0.01% atropine with orthokeratology in childhood myopia control (AOK) study: a 2-year randomized clinical trial. Cont Lens Anterior Eye. 2023;46(1):101723. doi:10.1016/j.clae.2022.101723
- Xu S, Li Z, Zhao W, et al. Effect of atropine, orthokeratology and combined treatments for myopia control: a 2-year stratified randomised clinical trial. Br J Ophthalmol. 2022;bjophthalmol-2022-321272. doi:10.1136/bjo-2022-321272
- Chen Z, Zhou J, Xue F, Qu X, Zhou X. Two-year add-on effect of using low concentration atropine in poor responders of orthokeratology in myopic children. Br J Ophthalmol. 2022 Aug;106(8):1069-1072. doi: 10.1136/bjophthalmol-2020-317980. Epub 2021 Mar 11. PMID: 33707188.
- Jones JH, Mutti DO, Jones-Jordan LA, Walline JJ. Effect of combining 0.01% atropine with soft multifocal contact lenses on myopia progression in children. Optom Vis Sci. 2022;99(5):434-442. doi:10.1097/OPX.0000000000001884
- Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855. PMID: 37440213; PMCID: PMC10346510.
- Nucci P, Lembo A, Schiavetti I, Shah R, Edgar DF, Evans BJW. A comparison of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) spectacles, atropine, and combined DIMS/atropine. PLoS One. 2023;18(2):e0281816. doi:10.1371/journal.pone.0281816
- Huang Z, Chen XF, He T, Tang Y, Du CX. Synergistic effects of defocus-incorporated multiple segments and atropine in slowing the progression of myopia. Sci Rep. 2022;12(1):22311. doi:10.1038/s41598-022-25599-z
Some products covered in Review of Myopia Management are prescribed off-label in the United States because they are not FDA-approved for slowing the progression of myopia in children.
MiSight 1 Day soft contact lenses are FDA-approved for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes who, at the initiation of treatment, are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with less than or equal to 0.75 diopters of astigmatism.
