Spectacle Lenses With Highly Aspherical

Lenslets for Slowing Myopia: A Randomized,

Double-Blind, Cross-Over Clinical Trial

PADMAJA SANKARIDURG, REBECCA WENG, HUY TRAN, DANIEL P. SPIEGEL, BJÖRN DROBE, THAO HA,
YEN H. TRAN, AND THOMAS NADUVILATH

• PURPOSE: To evaluate myopia progression with highly 24. © 2022 The Authors. Published by Elsevier Inc.
aspherical lenslet (HAL) spectacles vs conventional sin- This is an open access article under the CC BY license
gle vision (SV) spectacles. (http://creativecommons.org/licenses/by/4.0/))
• DESIGN: Prospective, double-blind, single-center, ran-
domized, cross-over trial.

E
• METHOD: A total of 119 Vietnamese children (7-13 stimated to affect nearly half of the world’s
years of age, spherical equivalent refractive error [SE] = – population by the year 2050,1 the burden of myopia
0.75 to –4.75D) were randomized to wear either HAL or is substantial. For the year 2015 alone, the potential
SV, and after 6 months (stage 1) crossed over to the other lost productivity due to myopia was estimated at US $250
lens for another 6 months (stage 2). At the end of stage billion.2 It has been demonstrated that any level of myopia
2, both groups wore HAL for a further 6 months. In the confers a risk of complications; however, eyes with high my-
order that lenses were worn at each stage, group 1 was opia are at the greatest risk for complications and related
designated HSH (HAL-SV-HAL) and group 2 SHH (SV- vision impairment.3 Eyes with higher levels of myopia also
HAL-HAL). The main outcome measures were a com- have an earlier onset of complications affecting their pro-
parison between HAL and SV for change () in SE and ductivity.4 , 5 These data indicate the need to reduce progres-
axial length (AL) during each stage; and a comparison of sion of a myopic eye to reduce the burden.
SE/AL with SV between HSH and SHH groups to de- Optical strategies that not only correct for the refractive
termine whether myopia rebounded when switched from error at the fovea but also modulate the defocus at the pe-
HAL to SV (HSH group). ripheral retina can slow myopia. Of the spectacle lenses
• RESULTS: Myopia progressed more slowly with HAL designed to slow myopia, recent lens designs involving
than with SV during stages 1 and 2 (SE stage 1: –0.21 multiple lens segments and aspherical lenslets in the mid-
vs –0.27D, P = .317, stage 2: –0.05 vs –0.32D, P < peripheral to peripheral portion of the lens have demon-
.001; AL stage 1: 0.07 vs 0.14 mm, P = .004; stage strated good efficacy in randomized clinical trials as com-
2: 0.04 vs 0.17 mm, P < .001). SE/AL with SV was pared to that in control single vision spectacle groups.6 , 7
not different between the HSH and SHH groups (SE Although such long-term trials extending over 2 to 3 years
–0.33 ± 0.27D vs –0.27 ± 0.42D, P = .208; AL 0.17 are recommended to assess efficacy and rebound of my-
± 0.13mm vs 0.13 ± 0.15 mm, P = .092). An average opia,8 inherent difficulties in conducting such trials (cost,
of 14 hours per day of lens wear was reported with both resources, drop-outs, and myopia-related issues such as age-
lenses. related influences on progression) prohibit the evaluation
• CONCLUSIONS: In this cross-over trial, intergroup and of possible myopia control designs for their ability to slow
intragroup comparisons indicate that HAL slows myopia. myopia, confirmation of myopia control efficacy of existing
Children were compliant with lens wear, and data were designs, or assessment of rebound.
not suggestive of rebound when patients were switched Thus, we aimed to ascertain the efficacy of spectacle
from HAL to SV. (Am J Ophthalmol 2023;247: 18– lenses with highly aspherical lenslets in slowing progression
of myopia compared to single vision spectacle lenses using a
short- term, prospective, double-blind, randomized clinical
Supplemental Material available at AJO.com. trial involving cross-over of the interventions.
Accepted for publication October 29, 2022.
From the Brien Holden Vision Institute (BHVI), Sydney, Australia
(P.S., R.W., H.T., T.N.); School of Optometry and Vision Science, Uni-
versity of New South Wales (P.S., T.N.), Sydney, NSW, Australia; Essilor
R&D Centre Singapore (D.P.S., B.D.), Singapore; Haiyen Eye Care (T.H., METHODS
Y.H.T.), Ho Chi Minh City, Vietnam
Inquiries to Padmaja Sankaridurg, Level 4, Rupert Myers Building,
Gate 14, Barker Street, Kensington, NSW 2052, Australia; e-mail: This was a prospective, 2-arm, double-blind, randomized
p.sankaridurg@unsw.edu.au cross-over clinical trial conducted at Haiyen Eye Care, Ho
© 2022 THE AUTHORS. PUBLISHED BY ELSEVIER INC.
18 THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE 0002-9394/$36.00
(HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/) https://doi.org/10.1016/j.ajo.2022.10.021
Chi Minh City, Vietnam. A total of 119 children with my-
opia who were 7 to 13 years of age, with a spherical equiva-
lent refractive error ranging from −0.75D to −4.75D, astig-
matism no more than −1.50D, anisometropia of ≤1.00D,
and visual acuity of ≥0.05 logMAR, were enrolled. All en-
rolled children had normal ocular findings with no strabis-
mus or any ocular or systemic condition that might affect
progression or visual acuity through effects on the retina,
accommodation, or intraocular pressure. In addition, there
was no history of use of any prior myopia control procedures
or contact lenses. Parents of carers/caregivers of children
provided informed consent and were willing to attend the
scheduled study visits and to comply with the protocol. The
trial was approved by the Institutional Ethics Committee of
An Sinh Hospital, Ho Chi Minh City, adhered to the tenets
of the Declaration of Helsinki for experimentation on hu-
man subjects, and was conducted in accordance with the
ICH-GCP (International Conference on Harmonisation-
Good Clinical Practice) guidelines (ICH135/95). The trial
was registered with the National Institutes of Health (NIH)
GOV trial registry (NCT04048148), commenced on 31st
May 2019 and was completed on 26 May 2021.
Enrolled children were randomized to 2 groups: (1) group
HSH to spectacle lenses with highly aspherical lenslets
(HAL), and (2) group SHH to single vision (SV) spectacle
lenses. After 6 months of lens wear in their assigned group
(stage 1), participants were switched to the other, remain-
ing lens type (group HSH switched from HAL to SV, and
group SHH vice versa) without any wash-out period for an
additional 6 months of lens wear (stage 2). The random-
ization plan was overseen by the biostatistician and gen-
erated from http://www.randomization.com/ and uses the
Wichman-Hill Random Number Generator that incorpo-
rates balanced permutations of treatments whereby each
subject receives both lens types in random order. Block ran-
domization of block size 6 was used to generate the plan.
No baseline stratification was used. The randomization plan
was applied through the Clinic Data Management system,
and the system sequentially allocated each enrolled partic-
ipant according to the plan.
At the end of 12 months, both groups were invited to
continue to participate in the study and were prescribed
HAL spectacles (13-19 months) and monitored for a fur-
ther 6 months (Stage 3). Participants stayed in their as-
signed group until commencing wear of HAL from 13 to
19 months.
• LENS DESIGN, STUDY PROCEDURES, AND LENS WEAR:
Children were required to wear spectacle lenses for the wak-
ing hours consistent with the wearing pattern of a person
who is a full-time spectacle wearer. The control spectacle
lens was a standard single vision spectacle lens (polycarbon-
ate; Essilor), and the novel test lens comprised concentric
rings of highly aspherical lenslets (polycarbonate material;
Essilor). The lens design and the mechanism for myopia
control efficacy of the HAL lenses has been previously re-
VOL. 247 MYOPIA CONTROL WITH SPECTACLES
ported.7 , 9 Lens fitting was as per standard fitting procedures
adopted for single vision lenses with monocular pupillary
distance for horizontal centration and frame half-heights
+2 mm for vertical centration.
Following a baseline examination that included history
and visual acuity, eyes were cyclopleged and a cycloplegic
autorefraction and axial length measurement conducted.
Cycloplegia was performed with 2 drops of 1% cyclopen-
tolate (cyclopentolate hydrochloride; Alcon), 5 minutes
apart, preceded by a short-acting anaesthetic (proxymeta-
caine hydrochloride). Approximately 30 minutes follow-
ing instillation of the second drop of cyclopentolate, pupil-
lary response to light was assessed for nonresponsiveness to
light. When eyes were deemed to be cyclopleged (pupils di-
lated and nonresponsive to light), refractive error and ax-
ial length measurements were conducted using Shin Nip-
pon K 5001 (http://www.shin-nippon.jp) and Lenstar 900
(http://www.haag-streit.com). Spherical equivalent refrac-
tive error was based on the average of 5 reliable autorefrac-
tion measurements for each eye, and axial length was based
on 3 measurements. Cycloplegic refractive error was mea-
sured at the 6-month time point whereas axial length was
measured at 3-month time points in the study.
When the participants needed a spectacle lens (assigned
lens at each of the stages or when required), the prescrip-
tion was provided to a member of the study team who was
not involved in examining the participants. They then or-
dered the lenses based on the randomization code. Once the
lenses were received, a dispenser fitted the lenses per the
instructions. Both the participant and the clinician were
blinded to the assigned lens type throughout the study pe-
riod.
• DATA ANALYSIS: The primary outcome of the trial was
the 6 month change in spherical equivalent refractive error
and axial length. Based on previous findings for myopia pro-
gression among Asian children, and assuming a 20% drop
out rate, the minimum sample was set at 60 children per
group to detect a group difference of 0.25 ± 0.43 diopters
(D) between lens types with a significance of 5% and power
at 80% using a 2-tailed t distribution.10
Computed for each participant-eye, progression of spher-
ical equivalent refractive error and axial length were de-
fined as the change from the baseline within each stage and
were analyzed within a stage in a grouped format and be-
tween stages in a paired format.
Descriptive statistics such as mean and standard devia-
tion were used to describe the raw progression data between
groups and stages and are presented using box-and-whisker
plots.
Outliers were identified by setting a boundary (±1.5D
representing 3 × SD) in the linear relationship between
axial length and spherical equivalent progression (Supple-
mental Figure 1). A total of 7 and 5 eyes fell outside this
range for stage 1 and stage 2, respectively.
19
 Progression of spherical equivalent and axial length be-
tween stages were analyzed in a paired format using a linear
mixed model, with “stage” factored as repeated effects. The
order of assignment was accounted for by analyzing stage
differences according to the first allocated lens. A linear
mixed model that accounted for both fixed (study group)
and random factors was used to analyze progression in a
grouped format. Subject intercepts were used to account for
the correlation of 2-eye data. The model was adjusted for
confounders such as age, sex, parental myopia, and base-
line refractive error. Model-based estimated means for each
group, with 95% confidence limits, are reported.
Compliance, computed as the average of the number of
hours that lenses were worn each day of the week, was clas-
sified into a binary variable of ≥14 hours per day and <14
hours per day. Progression between study groups was an-
alyzed within the compliant and noncompliant group. A
participant’s complete visit data were not excluded if some
of the observations were missing. At baseline, cycloplegic
spherical equivalent refractive error was missing for 2 par-
ticipants and was imputed (simple imputation method) us-
ing subjective spherical equivalent and axial length/corneal
curvature ratio as covariates on a regression model with an
r2 of 0.9.11 Two-tailed distributions were used for inferential
statistics. The level of significance was set at 5%.
RESULTS
A total of 132 children were successfully enrolled and ran-
domized to 2 groups. Of these, 119 children were dispensed
with lenses. The early discontinuations/loss to follow-up
prior to dispensing were related to inability to return for the
follow-up visits (n = 5), loss to follow-up (n = 4), lack of co-
operation (n = 2), and latent phoria (n = 2). A total of 111
children completed stage 1 and crossed over to the other
lens type and continued for a further 6 months (stage 2).
During stage 1, 4 participants each discontinued from group
HSH and group SHH, respectively. The reason for discon-
tinuation was disinterest/relocation/lost contact (6 of 8 par-
ticipants), and the remaining 2 participants (4%) reported
discomfort with HAL. A total of 109 children completed
stage 2.
Of these, 105 participants agreed to participate in stage
3, in which both groups wore HAL for a further 6 months.
During the final stage 3, which coincided with the COVID
lockdown, a total of 16 participants (7 and 9 participants
from groups HSH and SHH respectively) were lost to
follow-up. Figure 1 depicts the flow of participants in the
trial, and Table 1 provides the characteristics of partici-
pants randomized to the 2 groups. There were no significant
differences between the study groups. During the study pe-
riod, there were no lens-related adverse events. There were
3 non−lens-related events: 2 participants presented with
bacterial conjunctivitis (1 of the participants was wearing
20 AMERICAN JOURNAL OF OPHTHALMOLOGY
HAL and the remaining participant was wearing SV), and
another participant presented with subconjunctival hem-
orrhage (during wear of HAL). All events resolved without
sequalae.
• CHANGE IN SPHERICAL EQUIVALENT REFRACTIVE ER-
ROR AND AXIAL LENGTH ACROSS STAGES: Table 2
presents the change in spherical equivalent refractive er-
ror and axial length across the 3 stages. Both unadjusted
and adjusted data are presented. The results indicate the
following: (1) reduced spherical equivalent and axial length
progression with HAL during stages 1 and 2; (2) similar pro-
gression with both groups of HAL during stage 3; and (3)
across all stages, a more consistent and comparable response
for axial length data than for spherical equivalent data.
During stage 1, there was a significant difference between
the groups (linear mixed model, change in spherical equiv-
alent: age and baseline refractive error, P = .004 and P
= .003, respectively; change in axial length: study group
and age, P = .004 and P < .001, respectively). The ob-
served mean change in spherical equivalent refractive er-
ror (−0.20 ± 0.31 D with HAL vs −0.27 ± 0.42 D with
SV, 26% reduction) and axial length (0.06 ± 0.15 mm with
HAL vs 0.13 ± 0.15 mm with SV, 54% reduction) was less
with HAL as compared to SV lenses, with the differences
being significant for change in axial length only.
During stage 2, eyes of patients who previously wore HAL
and switched to SV increased in progression. Conversely,
eyes of patients who switched from SV to HAL slowed in
progression. There was a significant difference between the
groups (linear mixed model, change in spherical equivalent:
study group and age, P < .001; change in axial length, study
group and age, P < .001) At the end of stage 2, the change
in spherical equivalent refractive error (observed mean of
−0.05 ± 0.37 D with HAL vs −0.33 ± 0.27 D with SV,
85%) and axial length (adjusted mean of 0.05 ± 0.12 mm
with HAL vs 0.17 ± 0.13 mm with SV, 71%) was signifi-
cantly less in eyes with HAL, and the differences were sig-
nificant.
During the final stage 3, in which both groups wore HAL,
there were no differences between the groups (P = .203,
linear mixed model).
In addition, the change in spherical equivalent and axial
length for only those participants who finished all 3 stages
of the trial is shown in Figure 2, and similarly demonstrates
reduced progression with HAL as compared to SV lenses
during stages 1 and 2. During stage 3, group HSH eyes (SV
lenses during stage 2) demonstrated a reduced progression
with HAL. In comparison, with group SHH eyes (HAL dur-
ing Stage 2), the axial length change was similar between
stages 2 and 3, but the change in spherical equivalent re-
fractive error was greater in stage 3 compared to stage 2.
• MYOPIA PROGRESSION WHEN SWITCHED FROM HAL TO
SV LENSES: The rate of progression with SV lenses during
stage 2 (HAL wearers in stage 1, HSH group) was compared
MARCH 2023
FIGURE 1. Flow of participants in the trial.

TABLE 1. Characteristics of Participants Dispensed With Lenses

Variable n HAL n Single Vision P Value

Age (y), mean ± SD 54 11.2 ± 1.6 65 10.9 ± 1.7 .437

Female:Male ratio (%) 54 23: 31 65 31: 34 .586

Parental myopia (%), 0:1:2 54 40.7:53.7: 5.6 65 49.2: 36.9: 13.8 .114
Cyclo SE (D) mean ± SD (range) 108 −3.47 ± 1.16 (−1.05 to −6.13) 130 −3.37 ± 1.22 (−0.58 to −6.30) .629
Axial length (mm), mean ± SD (range) 108 25.1 ± 0.8 (23.1 to 27.9) 130 24.9 ± 0.8 (23.0 to 26.3) .346

Cyclo SE = cycloplegic spherical equivalent; D = diopter; HAL = highly aspherical lenslet.

to the rate of progression with SV lenses in stage 1 (no prior
HAL experience, SHH group) and was not different (−0.33
± 0.27 D vs −0.27 D ± 0.42, P = .208 for SE and 0.17 ±
0.13 mm vs 0.13 ± 0.15 mm, P = .092 for AL).
The estimated mean rate of progression (for a child 11
years of age and adjusted for confounders) with SV for stage
1 was −0.25D (CI = −0.34 to −0.17 D) and 0.13mm
(CI = 0.10 to 0.17 mm) for SE and AL, respectively. Simi-
larly, the estimated mean rate of progression for stage 2 was.
−0.33D (CI = −0.43 to −0.22 D) and 0.17 mm (CI = 0.13
to 0.22 mm) for SE and AL.
• WEARING TIME PER DAY AND PROGRESSION: Both
HAL and SV lenses were worn on an average of 14 hours
per day (overall across visits: mean 14.1 ± 2.9 vs 13.9 ±
2.8 hours, P = .470, and median 15.0 ± 2.1 vs 15.0 ± 2.5
hours with HAL and SV lenses, respectively). Therefore,
progression was determined for those participants who wore
the lenses for ≥14 hours per day and <14 hours per day dur-
ing stages 1 and 2. The differences between the groups were
significant for stage 2; the data were suggestive of higher
progression for those wearing HAL for <14 hours per day
(Figure 3).

VOL. 247 MYOPIA CONTROL WITH SPECTACLES 21

 TABLE 2. Change in Spherical Equivalent and Axial Length: Observed and estimated means during each stage

Stage/Group Observed Means Adjusted Means

Group I: HSH Group II: SHH P Value Group I: HSH Group II: SHH

Stage 1: HAL vs SV SE (D) −0.20 ± 0.31 −0.27 ± 0.42 .317 −0.21 –0.27
(+0.30 to −1.10) (+1.10 to −1.43) (−0.10 to −0.32) (−0.17 to −0.36)
AL (mm) 0.06 ± 0.15 0.13 ± 0.15 .004 0.07 0.14
(–0.59 to 0.67) (–0.63 to 0.55) (0.02 to 0.11) (0.10 to 0.18)
Stage 2: SE (D) –0.33 ± 0.27 –0.05 ± 0.37 <.001 –0.32 –0.05
SV vs HAL (+0.35 to –1.13) (+1.25 to –1.15) (–0.24 to –0.41) (0.03 to –0.12)
AL (mm) 0.17 ± 0.13 0.05 ± 0.12 <.001 0.16 0.04
(–0.31 to 0.73) (–0.14 to 0.62) (0.12 to 0.19) (0.01 to 0.07)
Stage 3: HAL vs HAL SE (D) –0.16 ± 0.38 –0.26 ± 0.36 .203 –0.18 –0.27
(–0.08 to –0.24) (–0.18 to –0.33) (–0.07 to –0.30) (–0.16 to –0.37)
AL (mm) 0.05 ± 0.09 0.07 ± 0.11 .650 0.07 0.08
(0.03 to 0.07) (0.05 to 0.10) (0.04 to 0.10) (0.05 to 0.11)

AL = axial length; D = diopter; HAL = highly aspherical lenslet; HSH =HAL-SV-HAL; SE = spherical equivalent; SHH =SV-HAL-HAL;
SV = single vision.

FIGURE 2. Observed changes in spherical equivalent refractive error and axial length for participants who completed all stages.

switched from either HAL to SV or vice versa, the ability

of HAL to slow myopia was demonstrated.
DISCUSSION The HAL spectacle lenses comprise a clear central zone
that corrects for the distance refractive error of the eye. Be-
This cross-over randomized clinical trial design effectively
yond the clear central zone, highly aspherical lenslets are
demonstrates the ability of HAL to slow myopia in com-
arranged in a contiguous, ring format on the lens. There are
parison to single vision lenses. An intergroup difference
11 rings present from the center to the periphery of the lens,
between HAL and SV lenses was observed at each of the
and the lenslets are said to impose a volume of myopic defo-
stages 1 and 2. Furthermore, within each group (intra-
cus in front of the retina while correcting for the distance re-
group), when children acted as their own controls and
fractive error of the eye. In a previous clinical trial involving

22 AMERICAN JOURNAL OF OPHTHALMOLOGY MARCH 2023

FIGURE 3. Difference in progression in users wearing at <14 hours per day vs ≥14 hours per day. ∗ Significant difference.
Chinese children with myopia randomized to HAL, slightly
aspherical lenslets (SAL), or SV, both HAL and SAL were
found to slow myopia over a 2-year period. However, the
slowing of progression was greater with HAL and especially
over the long term, and some investigators have concluded
that a positive dose−response relation exists between my-
opia control efficacy and lenslet asphericity7 , 9 Specifically,
the reported change in spherical equivalent/axial length at
the end of 6 months of wear with SV was −0.34 ± 0.04
D/0.20 ± 0.01 mm and with HAL was −0.10 ± 0.04 D/0.08
± 0.01 mm.9 Our results, in an independent trial involv-
ing Vietnamese children with myopia, was similar for both
SV and HAL, and confirms the ability of HAL to slow
myopia.
In the current trial, each of the lens-wearing stages were
6 months in duration. Wearing HAL slowed myopia as
demonstrated by lower axial elongation, as compared to
wearing SV for both stages 1 and 2. In comparison, change
in spherical equivalent was significantly different only for
stage 2. Although the reasons for this varied efficacy with
respect to spherical equivalent are not entirely clear, across
all stages, greater variability was observed with change in
spherical equivalent refractive error as compared to change
in axial length. Indeed, AL measurements are more ac-
curate with variability between measurements and instru-
ments limited to a few microns, and therefore considered a
better predictor for monitoring progression.8 Another pos-
sibility is that the intergroup difference in spherical equiv-
alent for each stage is less than the anticipated 0.25 ± 0.43
D. If true, this would require a larger sample size to detect in-
tergroup differences smaller than 0.25D for spherical equiv-
alent. However, in a recent publication comparing HAL vs
SV,9 the intergroup difference at 6 months was 0.24 D, and
therefore our sample size estimates were reasonable. In addi-
tion, our data indicate a lower-than-expected standard de-
viation at 0.35 D, which translates to the study sample hav-
ing 80% power to detect a smaller intergroup difference of
VOL. 247 MYOPIA CONTROL WITH SPECTACLES
0.20 D. Using this criterion, the group difference of 0.07 D
in stage 1 was nonsignificant, whereas a difference of 0.27
D in stage 2 was significant. Another possibility, albeit re-
mote, is that in stage 2, the switch to SV from HAL in
the HSH group may have increased progression with SV
lenses (rebound) that would then translate to a greater in-
tergroup difference despite HAL performing similarly across
both stages. However, the progression rate with SV lenses
in the HSH group during stage 2 was similar to the pro-
gression rate in the SHH group during stage 1 (Figure 2).
These results confirm the performance of HAL and also
indicate no rebound when children switched from HAL
to SV lenses. Although rebound was assessed only after 6
months of lens wear, studies have demonstrated significant
myopia control efficacy at just 6 months of lens wear,6 , 9 , 12
and therefore it was deemed appropriate to assess rebound
at this stage. Nevertheless, it is appropriate that data from
trials of longer duration be considered, to further assess and
to determine rebound or a lack thereof with the use of HAL
lenses.
Authors of previous studies with myopia control contact
lenses had reported a relation between myopia control per-
formance and compliance in lens wear.12 , 13 In the present
study, during stage 2, HAL wearers with ≥14 hours per day
were found to have significant slowing of myopia as com-
pared to those with <14 hours per day, with little differ-
ences across the other groups and stages. Overall, compli-
ance to spectacle lens wear was high, with <30% of wearers
reporting that they wore spectacles for <14 hours per day.
Given the unequal sample size, the effects of compliance
were difficult to assess.
During stage 3, myopia progression slowed in those par-
ticipants who were wearing SV lenses during stage 2 (HSH
group). In the SHH group, despite the participants wearing
HAL during both stages 2 and 3, a greater myopic shift in
SE was observed during stage 3 as compared to stage 2. Al-
though previous studies found high accuracy and repeata-
23
bility of refractive error measurements using the Shin Nip-
pon autorefractor (within ±0.25 and ±0.50 D in 78% and
96% of adult participants),14 in younger children in whom
the accommodation is more active, inadequate cyclople-
gia may result in overestimation of myopia. Other possibil-
ities are that COVID-related lifestyle changes during stage
3 may have affected progression despite compliance with
assigned lens type,15 or that the finding is simply reflec-
tive of the variability in refractive error measurement tech-
nique, as the AL changes were comparable between stages 2
and 3.
The strength of the study was the double-blind, cross-
over nature of the trial, which allowed all participants to
experience both lens types and therefore enabled compar-
isons both across and within the groups. Furthermore, there
were few discontinuations during stages 1 and 2 of the trial.
However, the trial also has some limitations. Although ran-
domized and intentionally designed for cross-over after 6
months of lens wear, the short duration of the trial does
not permit evaluation of the long-term performance of the
lens. In addition, despite the double-blind nature of the trial
that involved masking of the lens type, children probably
would have been aware of the test lens type due to the na-
ture of the aspherical lenslets; however, this is unlikely to
have affected the outcome of the trial, especially with re-
lation to the primary outcomes of change in refractive er-
ror and axial length measurements. Furthermore, the more-
than-expected dropouts related to COVID, as well as the
lifestyle changes imposed by lockdown during stage 3 of the
trial, may have influenced the outcome of this stage and
cross-comparisons.
In summary, HAL spectacle lenses were effective in slow-
ing myopia, and the data did not indicate rebound of my-
opia upon discontinuation.

Funding/Support: The trial was supported in part by Essilor International, Brien Holden Vision Institute and Hai Yen Eye Care. Trial materials (ie, lenses)
were provided by Essilor.
Financial Disclosures: P.S. has received part travel support to present trial findings at International Myopia Conference, Rotterdam, 2022. D.S. is an
employee of Essilor. B.D. is an employee of Essilor International and inventor on patents related to highly aspherical lenslet designs. The trial was partly
funded by Essilor and lenses used in the study were supplied by Essilor. Essilor manufactures and sells spectacle lenses with highly aspherical lenslets. None
of the other authors report any financial disclosures or conflicts of interest. All authors attest that they meet the current ICMJE criteria for authorship.
Author contributions: P.S., R.W., and T.N. conceptualized the trial, performed the investigation, and acquired, analyzed and interpreted the data. B.D.
and D.S. participated in the trial design, review, and interpretation of the data. H.T. and Y.T. performed the investigation and acquired, analyzed, and
interpreted the data. P.S. drafted the manuscript, which was critically revised by all authors. All authors approved the final manuscript.
Data sharing statement: Restrictions apply to the availability of these data, and anonymized data will be available upon reasonable request.

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