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AimsTo evaluate the 1-year efficacy of two new myopia control spectacle lenses with lenslets of different asphericity.MethodsOne hundred seventy schoolchildren aged 8–13 years with myopia of −0.75 D to −4.75 D were randomised to receive spectacle lenses with highly aspherical lenslets (HAL), spectacle lenses with slightly aspherical lenslets (SAL), or single-vision spectacle lenses (SVL). Cycloplegic autorefraction (spherical equivalent refraction (SER)), axial length (AL) and best-corrected visual acuity (BCVA) were measured at baseline and 6-month intervals. Adaptation and compliance questionnaires were administered during all visits.ResultsAfter 1 year, the mean changes in the SER (±SE) and AL (±SE) in the SVL group were −0.81±0.06 D and 0.36±0.02 mm. Compared with SVL, the myopia control efficacy measured using SER was 67% (difference of 0.53 D) for HAL and 41% (difference of 0.33 D) for SAL, and the efficacy measured using AL was 64% (difference of 0.23 mm) for HAL and 31% (difference of 0.11 mm) for SAL (all p<0.01). HAL resulted in significantly greater myopia control than SAL for SER (difference of 0.21 D, p<0.001) and AL (difference of 0.12 mm, p<0.001). The mean BCVA (−0.01±0.1 logMAR, p=0.22) and mean daily wearing time (13.2±2.6 hours, p=0.26) were similar among the three groups. All groups adapted to their lenses with no reported adverse events, complaints or discomfort.ConclusionsSpectacle lenses with aspherical lenslets effectively slow myopia progression and axial elongation compared with SVL. Myopia control efficacy increased with lenslet asphericity.Trial registration numberChiCTR1800017683.

AimsTo determine myopia progression in children who continued to wear the defocus incorporated multiple segments (DIMS) lenses or switched from single vision (SV) to DIMS lenses for a 1-year period following a 2-year myopia control trial.Methods128 children participated in this study. The children who had worn DIMS lenses continued to wear DIMS lenses (DIMS group), and children who had worn SV lenses switched to wear DIMS lenses (Control-to-DIMS group). Cycloplegic spherical equivalent refraction (SER) and axial length (AL) were measured at 6-month interval. Historical controls were age matched to the DIMS group at 24 months and used for comparing the third-year changes.ResultsOver 3 years, SER and AL changes in the DIMS group (n=65) were −0.52±0.69D and 0.31±0.26 mm; these changes were not statistically significant over time (repeated measures analysis of variance, p>0.05).SER (−0.04±0. 38D) and AL (0.08±0.12 mm) changes in the Control-to-DIMS group (n=55) in the third year were less compared with the first (mean difference=0.45 ± 0.30D, 0.21±0.11 mm, p<0.001) and second (0.34±0.30D, 0.12±0.10 mm, p<0.001) years.Changes in SER and AL in both groups over that period were significantly less than in the historical control group (DIMS vs historical control: mean difference=−0.18±0.42D, p=0.012; 0.08±0.15 mm, p=0.001; Control-to-DIMS versus historical control: adjusted mean differences=−0.30±0.42D, p<0.001; 0.12±0.16 mm, p<0.001).ConclusionsMyopia control effect was sustained in the third year in children who had used the DIMS spectacles in the previous 2 years and was also shown in the children switching from SV to DIMS lenses.

PurposeTo investigate the effect of low-intensity red-light (LRL) therapy on myopic control and the response after its cessation.MethodsA prospective clinical trial. One hundred two children aged 6 to 13 with myopia were included in the LRL group (n = 51) and the single-focus spectacles (SFS) group (n = 51). In LRL group, subjects wore SFS and received LRL therapy provided by a laser device that emitted red-light of 635 nm and power of 0.35 ± 0.02 mW. One year after the control trial, LRL therapy was stopped for 3 months. The outcomes mainly included axial length (AL), spherical equivalent refraction (SER), subfoveal choroidal thickness (SFCT), and accommodative function.ResultsAfter 12 months of therapy, 46 children in the LRL group and 40 children in the SFS group completed the trial. AL elongation and myopic progression were 0.01 mm (95%CI: − 0.05 to 0.07 mm) and 0.05 D (95%CI: − 0 .08 to 0.19 D) in the LRL group, which were less than 0.39 mm (95%CI: 0.33 to 0.45 mm) and − 0.64 D (95%CI: − 0.78 to − 0.51 D) in the SFS group (p < 0.05). The change of SFCT in the LRL group was greater than that in the SFS group (p < 0.05). Accommodative response and positive relative accommodation in the LRL group were more negative than those in the SFS group (p < 0.05). Forty-two subjects completed the observation of LRL cessation, AL and SER increased by 0.16 mm (95%CI: 0.11 to 0.22 mm) and − 0.20 D (95%CI: − 0.26 to − 0.14 D) during the cessation (p < 0.05), and SFCT returned to baseline (p > 0.05).ConclusionsLRL is an effective measure for preventing and controlling myopia, and it may also have the ability to improve the accommodative function. There may be a slight myopic rebound after its cessation. The effect of long-term LRL therapy needs to be further explored.Trial registrationChinese Clinical Trial Registry: Chinese Clinical Trails registry: ChiCTR2100045250. Registered 9 April 2021; retrospectively registered. http://www.chictr.org.cn/showproj.aspx?proj=124250

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.

Atropine eye drops and myopic retinal defocus each slow progression of myopia (short-sight). They also cause thickening of the choroid, and it has been suggested that the thickening is a precursor for reduced eye growth and slowed myopia progression. We investigated whether choroidal thickening due to optical defocus would add to thickening due to atropine when both were applied simultaneously. Addition would suggest that combining the two clinical treatments may improve efficacy of myopia control. We studied 20 children receiving 0.3% atropine daily for myopia control, over a period of 6 months. We imposed short periods of retinal defocus (1 h of myopic or hyperopic defocus (± 2.00D)) both before, and after 1 week and 3 and 6 months of atropine treatment. Prior to atropine, myopic or hyperopic defocus caused significantly thicker or thinner choroids respectively (± 12 µm, p < 0.001). After one week of atropine alone, thickness had increased (+ 21 µm; SD 17 µm; p < 0.001), and it increased further (by + 13 µm; SD 6 µm; p < 0.001) when exposed to myopic defocus. Atropine abolished choroidal thinning in response to hyperopic defocus. These effects remained the same after 3 and 6 months of atropine treatment. Our results show that additive effects of atropine and optical defocus are present at the level of the choroid, and suggest that combining optical and pharmaceutical treatments is likely to enhance efficacy of clinical myopia control.

The current study aimed to examine the short-term choroidal response to optical defocus in schoolchildren. Myopic schoolchildren aged 8-16 were randomly allocated to control group (CG), myopic defocus group (MDG) and hyperopic defocus group (HDG) (n = 17 per group). Children in MDG and HDG received additional +3D and -3D lenses, respectively, to their full corrections on the right eyes. Full correction was given to their left eyes, and on both eyes in the CG. Axial length (AXL) and subfoveal choroidal thickness (SFChT) were then measured by spectral domain optical coherence tomography. Children wore their group-specific correction for 2 hours after which any existing optical defocus was removed, and subjects wore full corrections for another 2 hours. Both the AXL and SFChT were recorded hourly for 4 hours. The mean refraction of all subjects was -3.41 ± 0.37D (± SEM). SFChT thinned when exposed to hyperopic defocus for 2 hours but less thinning was observed in response to myopic defocus compared to the control group (p < 0.05, two-way ANOVA). Removal of optical defocus significantly decreased SFChT in the MDG and significantly increased SFChT in the HDG after 1 and 2 hours (mean percentage change at 2-hour; control vs. hyperopic defocus vs. myopic defocus; -0.33 ± 0.59% vs. 3.04 ± 0.60% vs. -1.34 ± 0.74%, p < 0.01). Our results showed short-term exposure to myopic defocus induced relative choroidal thickening while hyperopic defocus led to choroidal thinning in children. This rapid and reversible choroidal response may be an important clinical parameter in gauging retinal response to optical defocus in human myopia.

ObjectiveSpectacle lenses with highly aspherical lenslets (HAL) and slightly aspherical lenslets (SAL) showed effective myopia control. This study was to investigate their effects on macular choroidal thickness (ChT) in myopic children.MethodsExploratory analysis from a 2-year, double-masked, randomised trial. 170 children aged 8–13 years with myopia between −0.75D and −4.75D, astigmatism of 1.50D or less, and anisometropia of 1.00D or less were recruited. Participants were randomly assigned in a 1:1:1 ratio to receive HAL, SAL or single vision spectacle lenses (SVL). The subfoveal, parafoveal and perifoveal ChT were evaluated every 6 months.Results154 participants completed all examinations. The ChT showed significant changes over time in all three groups in all regions (all p<0.05). The ChTs continuously decreased in the SVL group (ranging from −20.75 (SD 22.34) μm to −12.18 (22.57) μm after 2 years in different regions). Compared with the SVL group, ChT in the SAL group decreased less (ranging from −16.49 (21.27) μm to −5.29 (18.15) μm). In the HAL group, ChT increased in the first year and then decreased in the second year (ranging from −0.30 (27.54) μm to 8.92 (23.97) μm after two years). The perifoveal ChT decreased less than the parafoveal ChT, and the superior region decreased the least.ConclusionsThe ChT of the macula decreased after 2 years of myopia progression with SVL. Wearing spectacle lenses with aspherical lenslets reduced or abolished the ChT thinning and HAL had a more pronounced effect.Trial registration numberChiCTR1800017683.

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.

AimTo evaluate and compare the efficacy of combination treatment using 0.025% atropine and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses to 0.025% atropine and single vision (SV) spectacle lenses in slowing myopia progression in children with myopia.MethodsRandomised controlled trial conducted on children aged 4–16 years with myopia between −1.00D and −6.00D and astigmatism ≤2.00D. Children were randomly allocated into two groups: 0.025% atropine and SV spectacle lenses treatment group (group A), and 0.025% atropine and DIMS spectacle lenses treatment group (group B). Cycloplegic spherical equivalent refraction (SER) and axial length were measured at baseline, 6 and 12 months.Results102 patients completed the 12-month follow-up: n=49 in group A, mean age 9.50±2.78 years and n=53 in group B, mean age 9.90±2.47 years. At 12 months, the mean AL±SD change was 0.18±0.16 mm in group A and 0.07±0.16 mm in group B (mean difference: 0.11, 95% CI: 0.05 to 0.17; p≤0.001). Mean SER±SD progression at 12 months was −0.19±0.42D and −0.09±0.35D in groups A and B, respectively (p=0.13). 39.6% of children in group B had no axial elongation over 12 months compared with 12.2% of the children in group A (p=0.002).ConclusionsCombination treatment with 0.025% atropine and DIMS spectacle lenses is more effective in controlling axial elongation than 0.025% atropine with SV lenses. Although not significant, SER differences between groups were lower in group B. These findings support a potential additive effect of the two treatments.

PurposeTo investigate the long-term effect of orthokeratology (ortho-k) on the choroidal thickness and choroidal contour in myopic children.MethodsSubjects were from a conducted 2-year randomised clinical trial. Children (n=80) aged 8–12 years with spherical equivalent refraction of −1.00 to −6.00D were randomly assigned to the control group (n=40) and ortho-k group (n=40). Optical coherence tomography images were collected at the baseline, 1-month, 6-month, 12-month, 18-month and 24-month visits, then the choroidal thickness and choroid contour were calculated. Axial length (AL) and other ocular biometrics were also measured.ResultsDuring 2 years, in the control group, the choroidal thickness became thinning and the choroidal contour became prolate with time at all visits (all p<0.001). Ortho-k can improve the choroidal thickness (all p<0.001) and maintain the choroidal contour at all visits (all p<0.05). In the ortho-k group, the choroidal contour was less changed in the temporal than nasal (p=0.008), and the choroidal thickness was more thickening in the temporal 3 mm (p<0.001). Two-year change in choroidal thickness was significantly associated with the 2-year AL change in the control group (r=−0.52, p<0.001), however, this trend was broken by ortho-k (r=−0.05, p=0.342). After being adjusted by other variables in the multivariable regression model, the effect of ortho-k on choroidal thickness was stable.ConclusionsIn the current 2-year prospective study, ortho-k can improve the choroidal thickness and maintain the choroidal contour, but this effect diminished in a long term. Further study with larger sample size and longer follow-up is warranted to refine this issue.