|Ahead of print publication
Original article: Myopia control utilizing low-dose atropine as an isolated therapy or in combination with other optical measures: A retrospective cohort study
Nir Erdinest1, Naomi London2, Itay Lavy3, Nadav Levinger4, Eran Pras5, Yair Morad6
1 Department of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem; The Myopia Center, Rishon LeZion, Israel
2 Private Practice, Jerusalem, Israel
3 Department of Ophthalmology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel
4 Enaim Refractive Surgery Center, Jerusalem, Israel
5 Department of Ophthalmology, Assaf Harofeh Medical Center, Zerifin, Israel
6 The Myopia Center, Rishon LeZion; Department of Ophthalmology, Assaf Harofeh Medical Center, Zerifin, Israel
|Date of Submission||04-Apr-2022|
|Date of Acceptance||17-May-2022|
|Date of Web Publication||01-Aug-2022|
Private Practice, 5 Even Israel St., Jerusalem
Source of Support: None, Conflict of Interest: None
PURPOSE: To assess the additive potency of low-dose atropine combined with optical measures designed to decrease myopia progression.
MATERIALS AND METHODS: This retrospective study included 104 myopic children aged 5–12 over 4 years, divided into five groups: daily instillation of 0.01% atropine and distance single-vision spectacles (A), 0.01% atropine and progressive addition lenses (A + PAL), 0.01% atropine and soft contact lens with peripheral blur (A + CL). Two control groups were included, prescribed bifocal spectacles or single vision (SV) spectacles. Cycloplegic spherical equivalence refraction was measured biannually, including 1 year after cessation of treatment.
RESULTS: A significant decrease in myopia progression was noted during the 2nd and 3rd years of atropine treatment: A −0.55 ± 0.55D, −0.15 ± 0.15, −0.12 ± 0.12D were 1st, 2nd, 3rd years, respectively, A + PAL −0.47 ± 0.37D, −0.10 ± 0.25D, and −0.11 ± 0.25D were 1st, 2nd, 3rd years, respectively, A + CL −0.36 ± 0.43D, −0.13 ± 0.29D, and −0.10 ± 0.27D were 1st, 2nd, 3rd years, respectively. Myopia progression over 3 years, respectively, was −0.82 ± 0.50D, −0.70 ± 0.69D, −0.59 ± 0.66D in the bifocal group and −1.20 ± 1.28D, −0.72 ± 0.62D, −0.65 ± 0.47D in the SV group. One year after cessation of atropine treatment, myopia progression was − 0.32 ± 0.31D in A, −0.23 ± 0.28D in A + PAL, and −0.18 ± 0.35D in A + CL.
CONCLUSION: Atropine 0.01% presented as effective at decelerating myopia progression, more prominent in the 2nd and 3rd years of treatment. Combining atropine 0.01% with optical modalities exhibited a trend for added efficacy over monotherapy. A + CL exhibited the least rebound effect 1 year after cessation of treatment.
Keywords: Atropine, myopia, myopia control, myopia progression
|How to cite this URL:|
Erdinest N, London N, Lavy I, Levinger N, Pras E, Morad Y. Original article: Myopia control utilizing low-dose atropine as an isolated therapy or in combination with other optical measures: A retrospective cohort study. Taiwan J Ophthalmol [Epub ahead of print] [cited 2023 Jan 28]. Available from: https://www.e-tjo.org/preprintarticle.asp?id=353132
| Introduction|| |
Myopia is the most common refractive error worldwide, and its growing frequency is considered an epidemic spanning the entire literate world., Untreated, progressive myopia sometimes leads to severe complications affecting vision, ocular alignment, and even blindness. Both genetic and environmental factors influence myopia occurrence and progression, and some seem to be closely linked to each other.,, Lack of outdoor activity and high levels of education, possibly related, are probably important factors. Excessive and prolonged accommodation associated with near work is another possible catalyst for axial elongation by releasing chemical mediators that induce scleral and retinal growth. Hyperopic peripheral retinal blur is a risk factor for myopia development, while myopic peripheral blur may decrease progression.
The search for a treatment to arrest myopia progression yielded several recommendations, including increased outdoor activity, diluted atropine, orthokeratology, bifocal or progressive addition spectacle lenses, and soft multifocal center-near peripheral-blur contact lenses.
This study attempted to ascertain whether 0.01% atropine is more effective combined with progressive addition spectacle lenses or soft bifocal contact lenses. We included two control groups, one wearing bifocal spectacle lenses and a group wearing monotherapy single vision (SV) spectacles distance lenses. The study was conducted over 4 years, including a 3-year treatment period and a 1-year washout period, to observe if any therapy would display a rebound effect.
| Materials and Methods|| |
The study included 104 myopic children with an average age of 10.1 ± 2.1 (52% females) with a refractive error of 1.25–9.00D (median −4.50D, average −4.40 ± 2.31D) who underwent myopia control intervention followed over 4 years. One hundred and two children were of Jewish Caucasian descent, two of Arabic Middle-Eastern descent.
This study followed the tenets of the Helsinki Declaration. The Medical Center Institutional Review Board approval was obtained for this study and all of the procedures were carried out per their guidelines (approval number: 0345-21-HMO). The parents were aware that their children were participating in this study.
Inclusion and exclusion criteria
Inclusion criteria were a cycloplegic spherical equivalent refraction (SER) equal to or above −1.00D in each eye and a best-corrected visual acuity (VA) of 6/9 or better in each eye. The children all had documented myopic progression of at least −0.75D in the year before beginning this study.
Exclusion criteria included any systemic or ocular diseases such as connective tissue disorders or strabismus or had any previous atropine therapy (for myopia progression or amblyopia). Children with astigmatism >2.00D, and anyone with current or prior rigid gas permeable contact lens experience, including orthokeratology lenses, were excluded. Children wearing spherical or astigmatic soft contact lenses ceased lens wear for 2 or 4 weeks, respectively, before the commencement of treatment.
The clinic that conducted this study primarily treats patients that come precisely because they are interested in myopia control and routinely provides both monotherapy and combination therapies. The participants in each study group were determined using multiple considerations, including the severity of myopia, the rate of progression before consultation, and the child's willingness or caregivers to wear contact lenses with atropine. The charts from 2015 to 2019 were reviewed, and any that met the criteria mentioned above were included.
The children were divided into five groups matched for age, gender, and SER. Twenty instilled low-dose0.01% atropine (A), twenty were prescribed ophthalmic progressive addition lenses (PAL) with a + 1.50D addition combined with 0.01% atropine treatment (A + PAL), 22 were prescribed soft contact lenses with an aspheric concentric ring up to a + 3.00D addition combined with 0.01% atropine treatment (A + CL). The control groups consisted of 18 children prescribed bifocal spectacles with a + 2.00D addition and a group of 24 children prescribed SV spectacles for best-corrected distance acuity [Table 1].
Average myopia progression during the year before commencement of this study was 1.22 ± 0.42D in the A group, 1.30 ± 0.54D in the A + PAL group, 1.37 ± 0.57D in the A + CL group, 1.31 ± 0.64D in the bifocal group, and 1.15 ± 0.46D in the SV group.
The SER of each eye was measured by cycloplegic subjective refraction at each follow-up.
A chain pharmacy provided the preparation of atropine sulfate 0.01% (Super-Pharm Professional, Petach-Tikva, Israel). The drops were packaged in opaque (to prevent photodegrading), 10.0 ml sterile bottles with 5 ml volume of preparation preserved with Benzalkonium chloride 0.01%. The bottles were stored no longer than 21 days at 4°C. The parents of the appropriate groups were instructed to instill one drop daily before bedtime.
The children wearing the FT-28 bifocal (Shamir, Kibbutz Usha, Israel) lenses and PAL spectacles (Optimize, Bdolach, Acre, Israel) were instructed to use the bottom area of the lens for near work.
The soft contact lenses were MF60 V1 + 3.00D addition (Soflex, A CooperVision Specialty Eye Care), CDGM3, a PolyHema 58% material for daily wear, replaced annually. The optic zone consisted of a 2 mm spherical center-distance area surrounded by an aspheric addition up to + 3.00D at 6 mm. The children were instructed to wear the lenses 7 days a week, and the parents were instructed to soak the lenses nightly in fresh one-step hydrogen-peroxide disinfecting solution.
The children were examined biannually throughout the 4 years of the study (including a 1-year washout). Refraction was measured after the instillation of tropicamide 1% twice, one drop instilled in each eye at 5-min intervals. Subjective refraction was performed post mydriasis (half an hour after instillation of the second drop) by the same practitioner in the same examination room with the children wearing the correction modality prescribed at the beginning of the study (bifocals, PALs, CL).
Distance VA was measured monocularly using the same Snellen chart using identical ambient lighting. After each follow-up visit, the optical devices were changed as per the newly measured refraction.
Cessation of atropine therapy
Atropine therapy cessation is a gradual process rendered under detailed guidelines to reduce possible subsequent rebound effects. This study implemented the discontinuance protocol at the end of 3 years under careful supervision.
Over 6 months, the number of atropine instillation days per week was reduced monthly (1 day per week, per month). For the 1st month posttreatment, the patient would instill atropine 6 days per week, during the 2nd month 5 days per week, during the 3rd month 4 days per week (every other day), and during the 4th month days 1, 3, and 5, during the 5th month on days 1 and 4 and during month 6 once a week.
Each patient underwent cycloplegic refraction and retinal examination at the end of months 7 and 6 months later.
The statistical analysis of myopia progression for each group during the year before the study was performed using the Statistical Package for the Social Sciences software 25.0 (SPSS Inc., Chicago, Illinois, USA) with one-way analysis of variance tests.
Statistical analysis comparing the treatment groups and myopic progression after treatment cessation were performed by Tukey-Kramer multiple comparisons test and Bonferroni multiple comparisons test, respectively, using the InStat software version 3.0 (GraphPad Software Inc., San Diego, CA). The statistical analysis of A + CL group VA was performed using the Statistical Package for the Social Sciences software 25.0 (SPSS Inc., Chicago, Illinois, USA) with two-tailed hypothesis tests.
| Results|| |
Of the 104 children that began this study, 99 completed the study. Of the 20 children in Group A, one withdrew at the suggestion of a community ophthalmologist. Two of the twenty withdrew from the A + PAL group. One felt the treatment was ineffective, and the other started wearing distance vision contact lenses. Of the 22 children prescribed A + CL, two did not complete the study as they were noncompliant and frequently did not wear the lenses. The children in the bifocal group (n = 18) and the control group (SV, n = 24) all completed the study.
The parents of five children reported red eyes after the instillation of drops during the first 2 days of treatment that disappeared after a few minutes. Subsequently, they reported no recurrence.
When first fitting the contact lenses, some children complained of halos or blurry distance vision. Objectively, the distance VA of nine children in the A + CL group was significantly impaired at the dispensing visit (P < 0.05), so the center distance optic zone was enlarged until complaints subsided and VA improved, all the while ensuring the addition of zone was in the pupil area.
Neither additional adverse events were reported during the 3 years of treatment nor during the year following cessation of drops.
Myopia progression during the year before treatment
The myopia progression during the year before the study between A, A + PAL, A + CL, bifocal, and SV groups was not statistically significant (P > 0.99). These results confirm that no group had a significantly lower or higher progression than the other groups.
The change in SER at the end of the 3-year treatment period was −0.83 ± 0.35D in the A group, −0.68 ± 0.32D in the A + PAL group, and −0.60 ± 0.35D in the A + CL group. Myopia increase was significantly higher in the nonatropine groups at −2.11 ± 0.54D in the bifocal spectacles group and −2.57 ± 0.88D in the SV spectacles control group.
There was profound statistical significance between the SV spectacles group and each of the three atropine groups, A, A + PAL, and A + CL (P < 0.001). The three atropine groups were each statistically more effective at decreasing myopia progression than the bifocal monotherapy group (P < 0.001). There was neither statistically significant difference between the A group and either the A + PAL or A + CL groups (P > 0.05), nor between the A + PAL group and A + CL group (P > 0.05). Overall, 0.01% atropine therapy exhibited higher statistical effectivity than other monotherapies, and combination therapies have a statistically significant additive effect [Figure 1].
|Figure 1: Myopia Progression During the 3-year Treatment Period. The progression of myopia (in diopters) of each group during the 3 years of treatment is displayed here. The groups are shown in ascending effectivity at decreasing myopia progression with their standard deviation from SV = single vision spectacles, bifocal, A = 0.01% atropine, A + PAL = A + ophthalmic progressive addition lenses, A + CL = A+ soft contact lenses with peripheral blur. The numbers in parenthesis represent the myopia progression in each group in that timeframe. *Represents statistical significance (P < 0.01) for treatments versus SV spectacles. **Represents statistical significance (P < 0.01) for treatments versus bifocal|
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A significant decrease in myopia progression was evident in the 2nd and 3rd years versus the 1st year in all atropine treatment groups. The A group increase during the 1st year was −0.55 ± 0.55D. In the 2nd year, the increase was only −0.15 ± 0.15D, statistically significantly less than the 1st year (P < 0.001), and the 3rd-year increase was −0.12 ± 0.12D, statistically significantly less than the 1st year (P < 0.01). A + PAL group increased −0.47 ± 0.37D during the 1st year but significantly less in comparison at −0.10 ± 0.25D (P < 0.001) and −0.11 ± 0.25D (P < 0.001) during the 2nd and 3rd years, respectively. A + CL treatment group increased −0.36 ± 0.43D during the 1st year of treatment, significantly less during the 2nd year −0.13 ± 0.29D (P < 0.05) and statistically less during the 3rd year than the 1st year as well −0.10 ± 0.27D (P < 0.05). Myopia progression, respectively, over 3 years was − 0.82 ± 0.50D, −0.70 ± 0.69D, −0.59 ± 0.66D in the bifocal group, and − 1.20 ± 1.28D, −0.72 ± 0.62D, −0.65 ± 0.47D in the SV group [Figure 1].
Myopia progression after atropine cessation
A rebound effect was measured 1 year after the cessation of treatment in all three atropine groups of −0.32 ± 0.31D in the A group, −0.23 ± 0.28D in the A + PAL group, and −0.18 ± 0.35D in A + CL group [Figure 2].
|Figure 2: Myopia Progression 1 year after Cessation of Treatment. Shown here is the rebound effect 1 year after terminating atropine treatment in groups A = 0.01% atropine, A + PAL = 0.01% atropine and ophthalmic progressive added lenses, A + CL = 0.01% atropine and soft contact lenses with peripheral blur. Error bars represent standard deviation. The numbers in parenthesis represent the myopia progression in each group during the year after cessation of treatment. *Represents statistical significance (P < 0.05) for treatments versus SV spectacles|
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There was no statistically significant difference between the A and A + PAL groups (P > 0.05), between the A and A + CL groups (P > 0.05), or between A + PAL and A + CL groups (P > 0.05).
| Discussion|| |
These results in this study presented an additive effect of combination of 0.01% atropine with other therapies, A + PAL and A + CL, over monotherapy treatments, over 3 years. Atropine monotherapy was quite effective, while the children in the bifocal monotherapy and the SV control group exhibited significant myopia progression during that same period.
Although the groups included only a small cohort, there exhibited in this study a significantly more potent myopia control over years two and three of treatment compared to the 1st year. A similar observation was noted in the Atropine and Myopia Control 2 (ATOM2) study, where the atropine of 0.01% proved more effective in year two. Understanding the potential timeline of effectivity is important when delineating options to parents interested in myopia management for their child.
In the ATOM2 study, 1 year after terminating treatment of group atropine 0.01%, the rebound effect was myopic progression of −0.28±0.33D, similar to the observations found in this study after 3 years of treatment. The combination therapies displayed even less of a rebound effect. After a year without treatment, each atropine group exhibited some rebound effect, the least of which was expressed in the A + CL group. There is a possible dual effect of the multifocal contact lens to inhibit myopia progression, including the myopic periphery, as well as the relaxation of accommodation and lessening of esophoria, more exophoria, which may have contributed. As these benefits are also (partially) present in the A + PAL and bifocal groups, which exhibited a higher progression, additional processes must be contributing. Though we did not measure this precisely, we postulated the extra advantage may be because the children in this group tended to partake in more outdoor activities, as reported by their caregivers at the follow-up visits (data not shown), and possibly gleaned the benefit from the additional sunlight, a potential myopia progression inhibitor.
Chosen modalities in this study
At the outset of this study, it was acknowledged in the published literature that 0.01% low-dose atropine was the preferred concentration and most potent monotherapy to decrease myopia progression with minimal side effects. Current data are emerging that 0.05% may be the preferred concentration under certain circumstances.
The uniform + 2.00D addition in the bifocal group minimized variables and has proven to be an effective therapy to reduce accommodative strain as well as give segmental peripheral blur.,
There have been speculations regarding the additive effect of base-in prism to the addition of spectacle lens in myopia control. Research suggests that while it can be slightly more effective in subjects with a high lag of accommodation, did not significantly decrease progression, so it was not incorporated here.
There is an ongoing study to determine whether combining 0.01% atropine and a uniform + 2.50D addition center-distance soft bifocal contact lens slows myopia progression more than contact lens monotherapy. The difference here is that the children have a higher addition of + 3.00D.
The Bifocal Lenses in Nearsighted Kids, or BLINK study, which began in 2017, compared the effectivity of identical design single-vision, a center distance multifocal with a + 1.50D versus a + 2.50D addition. The study is ongoing, but the data so far suggest that a dioptric threshold or minimal area of the visual field may be required for the inhibitory effect, encouraging the use of the relatively high addition in this study.
While this study explored additive effectivity in combinations of 0.01% atropine with optical treatments, it did not include a group of children fit with orthokeratology, an effective monotherapy to decelerate myopia progression. This was both due to time consideration and to avoid possible corneal epithelial toxicity by the preservative in the atropine. Publication of the synergistic effects of orthokeratology and atropine at slowing myopia progression is available in the academic literature. The greater effect on axial elongation using combination orthokeratology and low-dose atropine over orthokeratology as a monotherapy has been exhibited and a similar 2-year study is underway.,
SER was measured after the instillation of tropicamide. This was selected instead of another locally commonly used drug for this purpose, cyclopentolate, or atropine, to avoid a possible bias. Cyclopentolate was used in the past as a treatment to halt myopia progression. In conjunction with subjective refraction, tropicamide 1% twice, one drop instilled in each eye at 5-min intervals provides an accurate measurement of refractive status.
While the goal is to find an effective broad-spectrum combination therapy, the results in this study indicate it may be prudent to pursue further avenues combining atropine treatment with isolated subgroups, including in each category only those proven the most impacted. It is possible that there would have been different outcomes both statistically and perhaps also clinically had the A + PAL group and the bifocal group been limited to only those with an esophoria posture and a high lag of accommodation.
The most effective addition in the periphery of the soft contact lens and the desired area of the pupil zone needed to create the effective myopic peripheral blur is still being researched. As that data emerges and is applied, the additive effect of the combination therapy potentially maybe even greater than what was found here.
A limitation of this study is its retrospective nature. In addition, this study included only a small cohort of children in each treatment modality, and each group, though comparable, was quite heterogenic concerning the range of refractive error. Although the children were divided as far as types of refraction and age fairly equally among the various treatment modality groups, treatment effectivity is influenced by baseline myopia as well as the age of myopia onset. Further randomized prospective research subdividing these characteristics is needed to confirm the results found here.
Many studies have defined the degree of myopia using the spherical equivalent, and others have used axial length. It has to be emphasized that this study is focused on the additive benefits of combined therapies to decrease myopia progression and not on specific sequelae. Not including additional measurements in this study does not indicate their lack of significance. Myopia progression is associated with axial elongation and is even considered a principal ocular component for endeavoring to decrease progression to prevent potential physiological consequences such as retinal shape, scleral, and choroid thinning posterior to the equator.
A formula derived from refraction and keratometry data utilizes this information which can predict with reasonable accuracy absolute axial length, but it is not accurate enough to use when trying to track small changes over time. The findings were similar using cycloplegic or noncycloplegic refraction. In studies such as ATOM2, the deceleration in myopia did not correlate linearly with a parallel deceleration in axial length. Studies have shown that untreated eyes with a longer axial length at baseline had a more significant increase over 4 year period.
In summary, this study acknowledges the probable axial elongation with an increase in myopia, if not linearly and without significant change in other parameters or physiology, and in the interest of time, did not include this measurement.
| Conclusions|| |
Low-dose atropine has been substantiated in this study as an effective treatment to decelerate myopia progression, consistent with previous research. When combined with PAL spectacles that address near-work behavior or peripheral blur contact lenses, the effect is additive. All three atropine groups were observed to be more effective in the 2nd and 3rd years of treatment compared to year one. One year after cessation of therapy revealed a minor rebound effect in all atropine groups. The least rebound effect was manifested in the combination of atropine with the bifocal contact lenses group. The cohort of this study is relatively small, and further investigations are encouraged to verify the results found here concerning the 3rd-year efficacy of treatment, the rebound effect, and the additive efficacy of topical atropine combined with other treatments.
Financial support and sponsorship
Conflicts of interest
The authors declare that there are no conflicts of interests of this paper.
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[Figure 1], [Figure 2]