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AimTo determine if ‘Defocus Incorporated Multiple Segments’ (DIMS) spectacle lenses slow childhood myopia progression.MethodsA 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8–13 years, with myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. Children were randomly assigned to wear DIMS (n=93) or single vision (SV) spectacle lenses (n=90). DIMS lens incorporated multiple segments with myopic defocus of +3.50 D. Refractive error (cycloplegic autorefraction) and axial length were measured at 6month intervals.Results160 children completed the study, n=79 in the DIMS group and n=81 in the SV group. Average (SE) myopic progressions over 2 years were −0.41±0.06 D in the DIMS group and −0.85±0.08 D in the SV group. Mean (SE) axial elongation was 0.21±0.02 mm and 0.55±0.02 mm in the DIMS and SV groups, respectively. Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference −0.44±0.09 D, 95% CI −0.73 to −0.37, p<0.0001). Likewise, children in the DIMS group had less axial elongation by 62% than those in the SV group (mean difference 0.34±0.04 mm, 95% CI 0.22 to 0.37, p<0.0001). 21.5% children who wore DIMS lenses had no myopia progression over 2 years, but only 7.4% for those who wore SV lenses.ConclusionsDaily wear of the DIMS lens significantly retarded myopia progression and axial elongation in myopic children. Our results demonstrated simultaneous clear vision with constant myopic defocus can slow myopia progression.Trial registration number NCT02206217.

PurposeTo evaluate the effects of 0.01% and 0.02% atropine eye drops on myopia progression, pupil diameter and accommodative amplitude in myopic children.MethodsA cohort study assessed 400 myopic children divided into three groups: 138 and 142 children were randomised to use either 0.02% or 0.01% atropine eye drops, respectively. They wore single-vision (SV) spectacles, with one drop of atropine eye drop applied to both eyes once nightly. Control children (n=120) only wore SV spectacles. Repeated measurements of spherical equivalent refractive errors (SERs), axial length (AL), pupil diameter and accommodative amplitude were performed at baseline, and 4, 8 and 12 months after treatment.ResultsAfter 12 months, the SER change was −0.38±0.35D, −0.47±0.45D, −0.70±0.60D and AL change was 0.30±0.21 mm, 0.37±0.22 mm, 0.46±0.35 mm in the 0.02%, 0.01% atropine and control groups, respectively. There were significant differences in the change in AL and SER between three groups (all p<0.001). Between baseline and the 12-month visit, the overall change in accommodative amplitude was 1.50±0.25D, 1.61±0.31D and change in pupil diameter was 0.78±0.42 mm, 0.69±0.39 mm, with 0.02% and 0.01% atropine, respectively. Accommodative amplitude significantly decreased and pupil diameter significantly increased in two atropine groups (all p<0.001). Moreover, there was no statistical difference in the change difference in accommodative amplitude and pupil diameter between two atropine groups (p=0.24, p=0.38), whereas the accommodative amplitude (p=0.45) and pupil diameter (p=0.39) in the control group remained stable.Conclusions0.02% atropine eye drops had a better effect on myopia progression than 0.01% atropine, but 0.02% and 0.01% atropine showed similar effects on pupil diameter and accommodative amplitude after 12 months of treatment.Trial registration numberChiCTR-IPD-16008844.

AimTo examine the safety and efficacy of low-dose atropine (0.01% and 0.1% loading dose) after 2-year treatment and 1-year washout in 6-year-old to 12-year-old Danish children with myopia.MethodsInvestigator-initiated, placebo-controlled, double-blind, randomised clinical trial. Of 124 screened children, 97 were randomised to receive 0.01% low-dose atropine for 24 months (0.01%) or 0.1% low-dose atropine for 6 months, then 0.01% for 18 months (0.1% loading dose) or placebo, followed by a 1-year washout. Altogether, 91 participants completed the study. The primary outcome was myopia progression (axial length (AL) and spherical equivalent refraction (SER)). Secondary outcomes were adverse events, ocular biometrical measurements and treatment responder eyes (myopia progression less than −0.50 diopters (D)). Constrained linear mixed models were constructed with individual eyes nested by participant ID, according to intention-to-treat. The responder analysis used Fisher’s exact test. Significance levels were adjusted for multiple comparisons. Adjusted p values <0.05 were considered significant.ResultsAt 3 years, the mean AL was −0.06 mm (95% CI −0.18; 0.07) and −0.09 mm (95% CI −0.21; 0.04) less compared with placebo in the 0.1% loading dose group and 0.01% group. Mean SER was −0.02 D (95% CI −0.30; 0.26) less and 0.17 D (95% CI −0.11; 0.45) more compared with placebo in the 0.1% loading dose group and 0.01% group. There was no significant group difference in the responder eyes.ConclusionThere was no difference in myopia progression between groups following washout. A 6-month 0.1% loading dose did not improve efficacy compared with 0.01%. The 0.1% loading dose showed a rebound effect after dose switching.

The prevalence of myopia is increasing globally. Complications of myopia are associated with huge economic and social costs. It is believed that high myopia in adulthood can be traced back to school age onset myopia. Therefore, it is crucial and urgent to implement effective measures of myopia control, which may include preventing myopia onset as well as retarding myopia progression in school age children. The mechanism of myopia is still poorly understood. There are some evidences to suggest excessive expansion of Bruch’s membrane, possibly in response to peripheral hyperopic defocus, and it may be one of the mechanisms leading to the uncontrolled axial elongation of the globe. Atropine is currently the most effective therapy for myopia control. Recent clinical trials demonstrated low-dose atropine eye drops such as 0.01% resulted in retardation of myopia progression, with significantly less side effects compared to higher concentration preparation. However, there remain a proportion of patients who are poor responders, in whom the optimal management remains unclear. Proposed strategies include stepwise increase of atropine dosing, and a combination of low-dose atropine with increase outdoor time. This review will focus on the current understanding of epidemiology, pathophysiology in myopia and highlight recent clinical trials using atropine in the school-aged children, as well as the treatment strategy in clinical implementation in hyperopic, pre-myopic and myopic children.

Myopia, characterized by excessive axial elongation of the eyeball, increases risks of having sight-threatening diseases and impose a financial burden to healthcare system. Although myopic control interventions showed their effectiveness in slowing progression, the efficacy varies between individuals and does not completely halt progression. The study aims to investigate the efficacy of combining 0.01% atropine administered twice daily with optical defocus for myopia control in schoolchildren. This is a prospective, parallel-group, single-blinded, randomized, active-control trial (ClinicalTrials.gov identifier: NCT06358755). Myopic schoolchildren with no previous myopic control interventions aged between 7 to 12 years will be recruited. They will be randomly allocated into two groups (n = 56 per group) after baseline measurement. Both groups will receive 0.01% atropine twice per day for 18 months (one drop in the morning and the other drop at night before bedtime). Defocus incorporated multiple segments (DIMS) spectacle lenses will be prescribed in atropine plus optical defocus (ATD) treatment group while single vision spectacle lenses will be given in atropine only (AT) group. Cycloplegic refraction and axial lengths will be monitored every 6 months over 18-month study period. The primary outcomes are changes in cycloplegic refraction and axial lengths relative to the baseline over the study period. The result will examine the combination effect of low dose atropine and myopic defocus on myopia control in a randomized controlled study. The findings will also explore the potential benefits of applying 0.01% atropine twice per day on myopic control and its potential side effects.

Background/aimsTo compare the effects of repeated low-level red light (RLRL) treatment on axial length growth and refractive error changes in myopic and premyopic children.MethodsSubjects were assigned randomly to four subgroups: myopia-RLRL group (M-RL), myopia-control group (M-C), premyopia-RLRL group (PM-RL) and premyopia-control group (PM-C). Subjects in the RLRL group completed a 12-month treatment composed of a 3 min RLRL treatment session twice daily, with an interval of at least 4 hours, for 7 days per week. Visits were scheduled before and at 1-month, 3-month, 6-month, 9-month and 12-month follow-up after the treatment. Repeated-measures analysis of variance was used to compare the spherical equivalent refractive errors (SE) and axial length (AL) changes between the groups across the treatment period.ResultsAfter 12 months of treatment, in the myopia group, SE and AL changes were −0.078±0.375 D and 0.033±0.123 mm for M-RL and −0.861±0.556 D and 0.415±0.171 mm for M-C; in the premyopia group, the progression of SE and AL was −0.181±0.417 D and 0.145±0.175 mm for PM-RL and −0.521±0.436 D and 0.292±0.128 mm for PM-C. PM-RL indicated a lower myopia incidence than PM-C (2.5% vs 19.4%). Additionally, the percentage of AL shortening in the M-RL was higher than that in the PM-RL before the 9-month follow-up.ConclusionRLRL effectively delayed myopia progression in children with myopia and reduced the incidence of myopia in premyopic children. Moreover, RLRL exhibited a stronger impact on myopic children compared with premyopic individuals.

Aims To determine if ‘Defocus Incorporated Soft Contact’ (DISC) lens wear slows childhood myopia progression. Methods A 2-year double-blind randomised controlled trial was carried out in 221 children aged 8–13 years, with myopia between −1.00 and −5.00 Dioptres (D) and astigmatism ≤1.00 D. Subjects were randomly assigned to the DISC (n=111) or single vision (SV; n=110) contact lens group. DISC lenses incorporated concentric rings, which provided an addition of +2.50 D, alternating with the normal distance correction. Refractive error (cycloplegic autorefraction) and axial length were measured at 6-month intervals. Differences between groups were analysed using unpaired t test. Results In total, 128 children completed the study, n=65 in the DISC group and n=63 in the SV group. Myopia progressed 25% more slowly for children in the DISC group compared with those in the control group (0.30 D/year; 95% CI −0.71 to −0.47 vs 0.4 D/year; 95% CI −0.93 to −0.65, p=0.031). Likewise, there was less axial elongation for children in the DISC versus SV groups (0.13 mm/year; 95% CI 0.20 to 0.31 vs 0.18 mm/year; 95% CI 0.30 to 0.43, p=0.009). Treatment effect correlated positively with DISC lens wearing time (r=0.342; p=0.005). Indeed, myopia in children who wore the DISC lenses for five or more hours/day progressed 46% (mean difference=−0.382 D, p=0.001; 95% CI −0.59 to −0.17) less than those in the SV group. Conclusions The daily wearing of DISC lens significantly slowed myopia progression and axial elongation in Hong Kong schoolchildren. The findings demonstrated that simultaneous clear vision with constant myopic defocus can retard myopia progression.

AimTo report refractive error prevalence and visual impairment in Republic of Ireland (henceforth 'Ireland') schoolchildren.MethodsThe Ireland Eye Study examined 1626 participants (881 boys, 745 girls) in two age groups, 6–7 years (728) and 12–13 years (898), in Ireland between June 2016 and January 2018. Participating schools were selected by stratified random sampling, representing a mix of school type (primary/postprimary), location (urban/rural) and socioeconomic status (disadvantaged/advantaged). Examination included monocular logarithm of the minimum angle of resolution (logMAR) presenting visual acuity (with spectacles if worn) and cycloplegic autorefraction (1% Cyclopentolate Hydrochloride). Parents completed a questionnaire to ascertain participants’ lifestyle.ResultsThe prevalence of myopia (spherical equivalent refraction (SER): ≤−0.50 D), hyperopia (SER: ≥+2.00 D) and astigmatism (≤−1.00 DC) among participants aged 6–7 years old was 3.3%, 25% and 19.2%, respectively, and among participants aged 12–13 years old was 19.9%, 8.9% and 15.9%, respectively. Astigmatic axes were predominately with-the-rule. The prevalence of ‘better eye’ presenting visual impairment (≥0.3 logMAR, with spectacles, if worn) was 3.7% among younger and 3.4% among older participants. Participants in minority groups (Traveller and non-white) were significantly more likely to present with presenting visual impairment in the ‘better eye’.ConclusionsThe Ireland Eye Study is the first population-based study to report on refractive error prevalence and visual impairment in Ireland. Myopia prevalence is similar to comparable studies of white European children, but the levels of presenting visual impairment are markedly higher than those reported for children living in Northern Ireland, suggesting barriers exist in accessing eye care.

PurposeTo compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period.MethodsSubjects aged 8 to 12 with myopia (−0.75 to −4.00 D sphere) and astigmatism (< −1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits.ResultsEighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n =  41 in the MiSight group (age: 11.01 ± 1.23 years, spherical equivalent: −2.16 ± 0.94 D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38 years, spherical equivalent: −1.75 ± 0.94 D, gender: male: 12, female: 21). After 2 years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28 mm vs 0.44 mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2 years compared to spectacle use.ConclusionsMiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children.ClinicalTrials.gov Identifier: NCT01917110.

AimsTo report the 1-year results of the efficacy of a defocus distributed multipoint (DDM) lens in controlling myopia progression in a multicentre, randomised controlled trial.MethodsOverall, 168 children aged 6–13 years were recruited and randomly assigned to wear a DDM lens (n=84) or single-vision (SV) lens (n=84) in three centres. Cycloplegic autorefraction (spherical equivalent refraction (SER)) and axial length (AL) were measured. Linear mixed model analysis was performed to compare between-group SER and AL changes. Logistic regression analysis was used to analyse the between-group difference in rapid myopia progression (SER increase≥0.75 D per year or AL growth≥0.40 mm per year).ResultsAfter 1 year, mean changes in SER were significantly lower in the DDM group (−0.47±0.37 D) than in the SV group (−0.71±0.42 D) (p<0.001). Similarly, mean changes in AL were significantly lower in the DDM group (0.21±0.17 mm) than in the SV group (0.34±0.16 mm) (p<0.001). After adjusting for age, sex, daily wearing time and parental myopia, rapid myopia progression risk was higher in the SV group than in the DDM group (OR=3.51, 95% CI: 1.77 to 6.99), especially for children who wore a lens for >12 hours per day, boys and younger children (6–9 years) with ORs (95% CIs) of 10.82 (3.22 to 36.37), 5.34 (1.93 to 14.78) and 8.73 (2.6 to 29.33), respectively.ConclusionsAfter 1 year, DDM lenses effectively retarded myopia progression in children. Longer daily wearing time of DDM lens improved the efficacy of myopia control. Future long-term studies are needed for validation.Trial registration number NCT05340699.