A novel Lenslet-ARray-Integrated spectacle lenses for myopia control: a one-year randomized, double-masked, controlled trial.

PURPOSE: To investigate the myopia control efficacy of novel Lenslet-ARray-Integrated (LARI) spectacle lenses with positive (PLARI) and negative (NLARI) power lenslets worn for one year in myopic children. DESIGN: Randomized, double-masked, controlled clinical trial. PARTICIPANTS: A total of 240 children, aged 6 to 12 years, with spherical equivalent refraction (SER) between -4.00 and -1.00 diopter (D), astigmatism of 1.50 D or less, and anisometropia of 1.00 D or less. METHODS: Participants were assigned randomly in a 1:1:1 ratio to PLARI, NLARI, and a control (single-vision (SV)) groups. Cycloplegic autorefraction and axial length were measured at baseline and 6-month intervals after lens wear. MAIN OUTCOME MEASURES: Changes in SER, axial elongation (AE), and differences between groups. RESULTS: After 1-year, SER changes and AE in the PLARI and NLARI groups were significantly less than those in the SV group (SER: -0.30 ± 0.48 D, -0.21 ± 0.35 D, -0.66 ± 0.40 D; AE: 0.19 ± 0.20 mm, 0.17 ± 0.14 mm, 0.34 ± 0.18 mm, respectively) (all P < 0.001). There were no significant differences in SER changes and AE between PLARI and NLARI groups (P = 0.54 and P = 1.00, respectively). Younger age was associated with more rapid SER increase and larger AE in the SV (r = 0.40, P < 0.001 and r = -0.59, P < 0.001, respectively) and PLARI (r= 0.46, P < 0.001 and r = -0.52, P < 0.001, respectively) groups, but not in the NLARI group (r = -0.002, P = 0.98 and r = -0.08, P = 0.48, respectively). CONCLUSIONS: Compared with the SV group, both PLARI and NARI groups showed significantly slower myopia progression in terms of SER and axial elongation. Faster myopia progression, in terms of both SER and AE, was associated with younger age in the SV and PLARI groups, but not in the NLARI group.

Dual-focus contact lenses for myopia control modify central retinal electrophysiology in humans.

INTRODUCTION: Dual-focus contact lenses create two focal planes, one providing a clear retinal image while the other imposes myopic defocus on the retina to slow myopia progression. This study used global-flash multifocal electroretinogram (gmfERG) response amplitudes to compare central versus peripheral retinal responses under dual-focus conditions and to assess the optimal degree of myopic defocus compared with a single-vision control lens. METHODS: Twenty participants each underwent three gmfERG trials, wearing a spectacle correction over dual-focus contact lenses with plano central power and peripheral secondary focal powers of either +2.00D, +4.00D or a plano single-vision lens. We compared amplitudes and latencies of the gmfERG direct and induced components (DC and IC) within participants, between the three different contact lens powers and at different retinal eccentricities (gmfERG ring). RESULTS: We observed significant differences in the gmfERG responses between the single-vision and dual-focus contact lenses. Overall, DC amplitudes peaked between zero and +2.00D secondary power, while IC amplitudes were maximal between +2.00D and +4.00D. Compared with the single-vision control, the greatest increase in DC and IC amplitudes while wearing dual-focus lenses occurred within the central 10° of the retina. There was no interaction effect between gmfERG ring (eccentricity) and secondary power, and no difference in the latency of the gmfERG responses between different powers. CONCLUSION: We found that dual-focus contact lenses with a +2.00D secondary power are close to that expected to induce the greatest increase in gmfERG responses relative to a single-vision lens. Dual-focus lenses produced the highest DC and IC response amplitudes relative to a single-vision lens in the central 10° of the retina. This suggests that dual-focus contact lenses slow myopia progression by modifying central rather than peripheral retinal activity.

Changes in relative peripheral refraction in children who switched from single-vision lenses to Defocus Incorporated Multiple Segments lenses.

PURPOSE: To investigate changes in relative peripheral refraction (RPR) associated with myopia progression in children who wore single-vision (SV) lenses for 2 years and switched to Defocus Incorporated Multiple Segments (DIMS) lenses in the third year versus children who wore DIMS lenses for 3 years. METHODS: In the first 2 years, children were allocated randomly to wear either DIMS or SV lenses. In the third year, children in the DIMS group continued to wear these lenses, while those in the SV group were switched to DIMS lenses (Control-to-DIMS group). Central and peripheral refraction and axial length were monitored every 6 months. RESULTS: Over 3 years, the DIMS group (n = 65) showed good myopia control and maintained a relatively constant and symmetrical RPR profile without significant changes. In the first 2 years, children who wore SV lenses (n = 55) showed asymmetrical RPR changes, with significant increases in hyperopic RPR at 20° nasal (N) (mean difference: 0.88 ± 1.06 D, p < 0.0001) and 30N (mean difference: 1.07 ± 1.09 D, p < 0.0001). The Control-to-DIMS group showed significant myopia retardation after wearing DIMS lenses in the third year. When compared with the RPR changes in the first 2 years, significant reductions in hyperopic RPR were observed at 20N (mean difference: -1.14 ± 1.93 D, p < 0.0001) and 30N (mean difference: -1.07 ± 1.17 D, p < 0.0001) in the third year. However, no significant difference between the RPR changes found in the nasal retina and temporal retina (p > 0.05) was noted in the third year. CONCLUSION: Symmetrical changes in RPR were found in children switching from SV to DIMS lenses, and a symmetrical pattern of RPR was noted in children who wore DIMS for 3 years. Myopia control using myopic defocus in the mid-periphery influenced the RPR changes and retarded myopia progression by altering the eye's growth pattern.

Comparison of peripheral refraction and higher-order aberrations between orthokeratology and multifocal soft contact lens designed with highly addition.

PURPOSE: To compare peripheral defocus, higher-order aberrations (HOAs), and contrast visual acuity (CVA) in myopic children wearing orthokeratology (OK) lenses and multifocal soft contact lenses (MSCLs) designed with highly addition. METHODS: This is a prospective, nonrandomized, controlled study. Subjects at 8 to 13 years of age with spherical equivalent refraction from - 1.00 to - 5.00 dioptres (D) were included in the OK group (n = 30) and MSCL group (n = 23). Relative peripheral corneal defocus (RPCD) and relative peripheral refraction (RPR) were measured before and after wearing lenses. HOAs including spherical aberration (SA), coma, trefoil, and total HOAs, and high (100%) and low (10%) CVA were compared between the groups. Axial length (AL) was measured before and after wearing the lenses for 1 year. RESULTS: After wearing the lenses, subjects in the MSCL group had RPCD and RPR values similar to the OK group at the paracentral (within 2 mm of the cornea or 20° of the retina, all p > 0.05) but larger than the OK group at the periphery (all p < 0.05). All HOAs increased after wearing the lenses except the trefoil in the MSCL group (all p < 0.05). HOAs increased more in the OK group (all p < 0.05). The 100% and 10% CVAs were worse in the MSCL group (p = 0.02 and p = 0.004). After 1 year, AL elongation was 0.37 mm (SD = 0.16) in the MSCL group and 0.28 mm (0.16) in the OK group (p = 0.06). CONCLUSION: MSCL produced larger myopic defocus at the periphery, increased less HOAs and had worse CVA than OK lens. The high addition of this MSCL did not result in better myopia control efficacy TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1800018564. Registered 25 September 2018; retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=31376.

Mechanism of Myopic Defocus or Atropine for Myopia Control: Different or Similar Ways?

INTRODUCTION: Myopia is usually caused by excessive elongation of the eye during development. This condition is common worldwide. In clinical practice, the progression of myopia is commonly controlled through optical or drug measures, but the specific mechanisms underlying these two treatments remain unclear. To verify whether the effects of these two treatments on posterior-pole tissues are similar or different, we studied a set of common transcriptional changes in chicken models. METHODS: Chicks were divided into four groups, and they were given the intervention measures of plus-lens induction, minus-lens induction, minus-lens induction with atropine injection, and minus-lens induction with saline injection. Then, the genetic changes in each tissue at the posterior pole were detected, and the results of different genes were compared. A semiquantitative real-time polymerase chain reaction method was used to further study the visually induced changes in the transcription of potential candidate genes. RESULTS: Based on RNA sequencing (RNA-seq) analysis of the transcriptome, we identified variations between the differentially expressed transcripts in three tissues from the two treatment groups. Through Kyoto Encyclopedia of Genes and Genomes enrichment analyses, eukaryotic protein translation elongation factor 1α2 (EEF1A2) was enriched in the "leishmaniasis" pathway in the choroid and showed increased expression in both the plus-lens induction and injection atropine groups. The expression levels of selected genes verified by quantitative real-time PCR were concordant with the RNA-seq data. CONCLUSIONS: Overlapping differentially expressed mRNAs of only one-tenth could suggest a different mechanism of myopic defocus and intravitreal injection of atropine controlling myopia. EEF1A2 might play an important role in the choroid during the treatment of myopia.

[Results of a two-year clinical study of myopia control with bifocal defocus-inducing soft contact lenses]. / Rezul'taty dvukhletnego klinicheskogo issledovaniya kontrolya miopii s pomoshch'yu bifokal'nykh defokusnykh myagkikh kontaktnykh linz.

The development of methods for myopia control remains one of the most topical trends in modern ophthalmology. Optical approaches to myopia control employ the induction of peripheral myopic defocus, which can be done with the use of multifocal soft contact lenses (SCLs). PURPOSE: To review the results of a two-year multicenter clinical study of myopia control with bifocal defocus-inducing SCLs. MATERIAL AND METHODS: The two-year study enrolled 100 patients aged 8 to 16 years who had mild or moderate bilateral myopia with spherical equivalent of (-)0.25 to (-)5.75 D. Based on the degree of myopia and the method of its correction, patients were divided into two main and two control groups. Multifocal SCLs with +4.0 D add power and monofocal SCLs were used for myopia correction. The results were evaluated by the clinical data of refraction, axial length and state of accommodation. The observation times were 3, 6, 12, 18 and 24 months. RESULTS: After 12 months of bifocal SCLs usage, signs of stabilization of myopia progression were identified in 72 and 73.5% of subjects of both main groups, after 24 months - in 54 and 79.5% of subjects, respectively. Statistically significant reduction in axial elongation amounting to 87-88% was also observed in patients using bifocal SCLs. A significant increase in positive relative accommodation (PRA) was observed in all groups. CONCLUSION: The study indicates the effectiveness of bifocal soft contact lenses in slowing the progression of mild and moderate myopia.

Global-flash mfERG responses to local differences in spherical and astigmatic defocus across the human retina.

PURPOSE: Emmetropisation is essentially a visually guided, within-eye process. We investigated differences in global-flash multifocal electroretinogram (gmfERG) responses to naturally occurring differences in spherical and astigmatic defocus across the retina, which might provide a basis for guiding eye growth. METHODS: Experiment 1: The gmfERG responses (direct, DC, and induced, IC, amplitudes and latencies) recorded simultaneously from six retinal areas (15° eccentricity, spaced at 60°, areas 3.2°2 ) were correlated with the uncorrected retinal defocus measured at the six corresponding retinal locations in 20 adults with foveal refractive errors (-4.75 to +1.25D). No correcting lenses were used to avoid introduction of lens-induced aberrations and magnification. Experiment 2 investigated the effect of superimposing astigmatic defocus (+2.00/-4.00D Jackson Cross Cylinder presented at four orientations) on gmfERG responses. RESULTS: Experiment 1: DC and IC response amplitudes were greater in retinal regions naturally exposed to more hyperopic spherical defocus (DC: rho = 0.26, p = 0.005; IC: rho = 0.29, p = 0.001), but response latencies were unaffected by sign or magnitude of spherical defocus (DC: p = 0.34; IC: p = 0.40). Response amplitudes and latencies were unaffected by astigmatic defocus. Experiment 2: Rotating the JCC axis to four different orientations had no effect on the gmfERG responses (DC amplitude, p = 0.39; DC latency, p = 0.10; IC amplitude, p = 0.51; IC latency, p = 0.64). CONCLUSION: The gmfERG responses from discrete retinal areas varied with the sign and magnitude of local spherical defocus, but we found no evidence that retinal responses were affected by astigmatic defocus. Therefore, local astigmatism is unlikely to provide cues for controlling eye growth, whereas differences in response to spherical defocus between different retinal regions could potentially provide cues for controlling eye growth in emmetropisation.

Influence of the time of day on axial length and choroidal thickness changes to hyperopic and myopic defocus in human eyes.

Research in animal models have shown that exposing the eye to positive or negative spectacle lenses can lead to predictable changes in eye growth. Recent research indicates that brief periods (1-2 h) of monocular defocus results in small, but significant changes in axial length and choroidal thickness of human subjects. However, the effects of the time of day on these ocular changes with defocus are not known. In this study, we examined the effects of monocular myopic and hyperopic defocus on axial length and choroidal thickness when applied in the morning (change between 10 a.m. and 12 p.m.) vs the evening (change between 5 and 7 p.m.) in young adult human participants (mean age, 23.44 ±â€¯4.52 years). A series of axial length (using an IOL Master) and choroidal thickness (using an optical coherence tomographer) measurements were obtained over three consecutive days in both eyes. Day 1 (no defocus) examined the baseline ocular measurements in the morning (10 a.m. and 12 p.m.) and in the evening (5 and 7 p.m.), day 2 investigated the effects of hyperopic and myopic defocus on ocular parameters in the morning (subjects wore a spectacle lens with +3 or -3 DS over the right eye and a plano lens over the left eye between 10 a.m. and 12 p.m.), and day 3 examined the effects of defocus in the evening (+3 or -3 DS spectacle lens over the right eye between 5 and 7 p.m.). Exposure to myopic defocus caused a significant reduction in axial length and thickening of the subfoveal choroid at both times; but, compared to baseline data from day 1, the relative change in axial length (-0.021 ± 0.009 vs +0.004 ± 0.003 mm, p = 0.009) and choroidal thickness (+0.027 ± 0.006 vs +0.007 ± 0.006 mm, p = 0.011) with defocus were significantly greater for evening exposure to defocus than for the morning session. On the contrary, introduction of hyperopic defocus resulted in a significant increase in axial length when given in the morning (+0.026 ± 0.006 mm), but not in the evening (+0.001 ± 0.003 mm) (p = 0.047). Furthermore, hyperopic defocus resulted in a significant thinning of the choroid (p = 0.005), but there was no significant influence of the time of day on choroidal changes associated with hyperopic defocus (p = 0.672). Exposure to hyperopic and myopic defocus at different times of the day was also associated with changes in the parafoveal regions of the choroid (measured across 1.5 mm nasal and temporal choroidal regions on either side of the fovea). Our results show that ocular response to optical defocus varies significantly depending on the time of day in human subjects. These findings represent a potential interaction between the signal associated with the eye's natural diurnal rhythm and the visual signal associated with the optical defocus, making the eye perhaps more responsive to hyperopic defocus (or 'go' signal) in the morning, and to myopic defocus (or 'stop' signal) in the latter half of the day.

Regional alterations in human choroidal thickness in response to short-term monocular hemifield myopic defocus.

PURPOSE: To examine the regional changes in human choroidal thickness following short-term exposure to hemifield myopic defocus using optical coherence tomography (OCT). METHODS: The central 26˚ visual field of the left eye of 25 healthy young adults (mean age 26 ± 5 years) was exposed to 60 min of clear vision (control session), +3 D full-field, +3 D superior retinal and +3 D inferior retinal myopic defocus, with the right eye occluded. Choroidal thickness across the central 5 mm (17°) macular region was examined before and after 60 min of defocus using a high-resolution, foveal centred vertical OCT line scan, with optical defocus simultaneously imposed using a Badal optometer and cold mirror system mounted on a Spectralis OCT device. RESULTS: Averaged across the central 5 mm macular area, choroidal thickness decreased by -4 ± 7 µm during the control session (p = 0.01), most likely due to the unique stimulus conditions of this study. The mean macular choroidal thickness increased during full-field (+2 ± 8 µm), inferior retinal (+3 ± 7 µm) and superior retinal myopic defocus (+5 ± 9 µm), representing a significant thickening of the choroid compared to the control session (all p < 0.05). The defocus induced changes in macular choroidal thickness differed between the superior and inferior hemiretinal regions (F2.26, 54.27  = 29.75, p < 0.001). When only the superior retina was exposed to myopic defocus, the choroid thickened in the superior region (+7 ± 8 µm, p < 0.001), but did not change significantly in the inferior region (+3 ± 9 µm, p = 0.12). When only the inferior retina was exposed to myopic defocus, the choroid thickened inferiorly (+4 ± 8 µm, p = 0.005), with no significant change observed in the superior region (+1 ± 8 µm, p = 0.46). CONCLUSIONS: These findings provide evidence supporting a local regional choroidal response to myopic defocus in the human eye, with hemifield myopic defocus leading to significant thickening of the choroid localised to the retinal region exposed to defocus. The novel finding of a localised response of the human choroid to hemifield myopic defocus, particularly in the superior hemiretina, may have important implications in optimising the optical design of myopia control interventions.

[Long-term results of perifocal defocus spectacle lens correction in children with progressive myopia]. / Otdalennye rezul'taty ochkovoi korrektsii s perifokal'nym defokusom u detei s progressiruiushchei miopiei.

Peripheral defocus plays a significant role in the formation of refraction. Perifocal spectacles allow differentiating correction of central and peripheral refraction of the eye along the horizontal meridian and can correct or reduce peripheral hyperopia. PURPOSE: To study the long-term results of wearing perifocal spectacles on the refraction in children with progressive myopia. MATERIAL AND METHODS: Perifocal spectacles were assigned to children of 7-14 years old with progressive myopia from -1.0 to -6.0 D in terms of refractive spherical equivalent. The children were examined before the prescription of perifocal spectacles and after 6 months, 12-18 months, 2 years, 3 years and 4-5 years. We measured visual acuity, the character of vision, refractive error before and after cycloplegia, performed biomicroscopy, ophthalmoscopy and biometry. Peripheral refraction was studied at 15° and 30° points in the nasal (N15 and N30) and temporal (T15 and T30) meridians without correction and while wearing perifocal spectacles. RESULTS: In perifocal spectacles, in the 15° zone, 100% of the eyes formed myopic defocus, which averaged -0.05±0.1 D in T15°, -0.25±0.16 D in N15° and -0.44±0.03 D in T30°. In the N30° zone, the hypermetropic defocus decreased by 4 times and amounted to 0.38±0.03 D. The rate of progression of myopia decreased from 0.8 D of baseline values to 0.17 D at 4-5 years of follow-up. After 6 months of wearing perifocal spectacles, the refraction gain was -0.2±0.02 D (in the control group it was -0.38±0.04 D), after 12-18 months - (-)0.38±0.04 D (-0.63±0.09 D in the control group), after 2 years - (-)0,78±0,06 D (-1.18±0,15 D in the control group), after 3 years - (-)0.99±0.12 D (-1.65±0.20D in the control group). During the 4-5 years of the follow-up, the refractive error in the main group was -1.16±0.2 D, which is 60% less than in the control group (-1.95±0.2 D). CONCLUSION: Constant wearing of perifocal spectacles reduces the rate of myopia progression in children by 4.5 times compared with the initial rate, and by 1.6 times (by 60%) in comparison with the control group. Perifocal spectacles are recommended as optical means to slow the progression of myopia.

[Correcting progressive myopia with bifocal contact lenses with central zone for distant vision: changes in accommodation and axial length (a preliminary report)]. / Korrektsiia progressiruiushchei miopii bifokal'nymi kontaktnymi linzami s tsentral'noi zonoi dlia dali: izmeneniia akkomodatsii i perednezadnei osi (predvaritel'noe soobshchenie).

PURPOSE: To assess the state of accommodation and the dynamics of changes of ocular axial length in patients with progressive myopia who use bifocal soft contact lenses (BFSCLs). MATERIAL AND METHODS: The main and control groups consisted of 50 children (100 eyes) each. Patients of the main group used BFSCLs with distance-oriented central zone and added power of 4 D on the periphery. Patients of the control group were corrected with spherical soft contact lenses (SSCLs). Baseline measurements included amplitude of accommodation (AA), positive relative accommodation (PRA) and the length of anterior-posterior axis of the eye. All patients were examined before wearing SCLs and every 3 months during the entire period of observation lasting 9 to 12 months. RESULTS: Correction of myopia with contact lenses is accompanied by the increase of AA and RPA. The users of BFSCLs with distance-oriented central zone and added power of 4 D on the periphery, which induces myopic peripheral defocus, had their accommodative function normalize much faster than the patients wearing SSCLs. The average increase in the ocular axial length in the BFSCLs group appeared to be significantly smaller than in the SSCLs group (0.11 and 0.58 D, respectively), which can be attributed to the simultaneous formation of the central focus and induced peripheral myopic defocus.

Effect of uncorrection versus full correction on myopia progression in 12-year-old children.

PURPOSE: To investigate the effects of no correction versus full correction on myopia progression in Chinese children over a period of 2 years. METHODS: Myopia was defined as cycloplegic spherical equivalent (SE) of ≤ -0.50 D. Uncorrection was defined as no spectacles worn, and full correction was defined as when the value of SE subtracted from the dioptric power of the child's current spectacles was less than 0.5 D. Ocular examinations included visual acuity, cycloplegic autorefraction, axial length and vertometer measurements. Questionnaires were completed by parents on behalf of the children. RESULTS: A total of 121 myopic children, with a median age of 12.7 years, were screened from the Anyang Childhood Eye Study, with 65 in the uncorrected group and 56 in the full correction group. At 2-year follow-up, children with no correction had slower myopia progression (-0.75 ± 0.49 D vs. -1.04 ± 0.49 D, P < 0.01) and less axial elongation (0.45 ± 0.18 mm vs. 0.53 ± 0.17 mm, P = 0.02) than children with full correction. In multivariate modeling, adjusting for baseline SE or axial length, age, gender, height, number of myopic parents, age at myopia onset, and time spent in near work and outdoors, children with no correction still had slower myopia progression (-0.76 ± 0.07 vs. -1.03 ± 0.08 D, P < 0.01) and less axial elongation (0.47 ± 0.03 mm vs. 0.51 ± 0.03 mm, P < 0.01). Myopia progression decreased significantly with an increasing amount of undercorrection in all children (r = 0.22, b = 0.16, P = 0.01). CONCLUSION: Our findings suggest that myopic defocus slows the progression of myopia in already myopic children, supporting previous findings from animal studies.

Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia Progression Among Taiwanese Schoolchildren: A Randomized Paired-Eye Clinical Trial.

INTRODUCTION: To evaluate the efficacy and safety of myopia control using a multifocal soft contact lens designed with high peripheral add power in schoolchildren. METHODS: This 1-year multi-center, prospective, randomized, double-blind, controlled study enrolled myopic schoolchildren aged 6-15 years with refractive errors between - 1.0 D and - 10.0 D. Each participant was randomly allocated to wear a daily disposable multifocal soft contact lens as the treatment in one eye and a single-vision soft contact lens as the control in the other eye. The primary endpoints were changes in the cycloplegic spherical equivalent (SE) and axial length at 1 year. RESULTS: Fifty-two of the 59 participants (88.1%) completed the study protocol. The mean change in SE was - 0.73 ± 0.40 D in the treatment group. and - 0.85 ± 0.51 D in the control group (mean difference: - 0.12 ± 0.34 D, p = 0.012). The mean change in axial length was 0.25 ± 0.14 mm in the treatment group, and 0.33 ± 0.17 mm in the control group (mean difference: 0.08 ± 0.10 mm, p < 0.001). The treatment was well tolerated, and no serious adverse events were observed. CONCLUSIONS: Treatment with multifocal soft contact lenses with high peripheral add power was effective in controlling the progression of myopia and axial length elongation in myopic schoolchildren.

Myopia Control Effect Is Influenced by Baseline Relative Peripheral Refraction in Children Wearing Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses.

The aim of this study is to investigate if baseline relative peripheral refraction (RPR) influences the myopia control effects in Chinese myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses. Peripheral refraction at 10°, 20°, and 30° nasal (10 N, 20 N, 30 N) and temporal (10 T, 20 T, 30 T) retina were measured at six-month intervals for children who participated in a 2-year randomized controlled trial. The relationship between the baseline peripheral refractions and myopia progression and axial length changes were analysed. A total of 79 children and 81 children in the DIMS and single vision (SV) group were investigated, respectively. In the DIMS group, more baseline myopic RPR spherical equivalent (SE) was associated with more myopic progression (10 N: r = 0.36, p = 0.001; 20 N: r = 0.35, p = 0.001) and greater axial elongation (10 N: r = −0.34, p = 0.001; 20 N: r = −0.29, p = 0.006) after adjusting for co-factors. In the SV group, baseline RPR had association with only myopia progression (10 N: r = 0.37, p = 0.001; 20 N: r = 0.36, p = 0.001; 30 N: r = 0.35, p = 0.002) but not with axial elongation after Bonferroni correction (p > 0.008). No statistically significant relationship was found between temporal retina and myopia progression or axial elongation in both groups. Children with baseline myopic RPR had statistically significant more myopia progression (mean difference around −0.40 D) and more axial elongation (mean difference 0.15 mm) when compared with the children having baseline hyperopic RPR in the DIMS group but not in the SV group. In conclusion, the baseline RPR profile may not influence future myopia progression or axial elongation for the SV lens wearers. However, DIMS lenses slowed down myopia progression and was better in myopia control for the children with baseline hyperopic RPR than the children with myopic RPR. This may partially explain why myopia control effects vary among myopic children. Customised myopic defocus for individuals may optimise myopia control effects, and further research to determine the optimal dosage, with consideration of peripheral retinal profile, is warranted.

Overview on Defocus Incorporated Multiple Segments Lenses: A Novel Perspective in Myopia Progression Management.

Myopia is becoming more common across the world, affecting approximately two billion people and rising. Different kinds of therapies (optical, pharmaceutical, environmental, or behavioral) have been proposed to decrease myopia progression, but with variable results and a lack of standardization. The evidence that targeted myopic defocus inhibits eye length growth has paved the way for several contact and spectacle lense designs to induce a peripheral defocus, thus slowing myopia progression, but the perfect configuration has yet to be defined. One of the newest and more promising approaches in this field is the use of Defocus Incorporated Multiple Segments (DIMS) lenses. These lenses are built from the assumption that targeted myopic defocus, produced by 396 mid-peripheral lenslets with positive power, inhibits eye length growth. Recent studies have highlighted the effectiveness of these lenses compared to children who had worn single vision spectacle lenses, in terms of myopia control and tolerability. Despite the evidence that these lenses can help slow down the progression of myopia, the occasional mid-peripheral aberrations they can induce, as well as the overall eye strain that comes with wearing them, should not be overlooked. The aim of this review is to give attention to the advantages and the shortfalls of this new approach and to evaluate its effectiveness in clinical practice.

Effect of Defocus Incorporated Multiple Segments Spectacle Lens Wear on Visual Function in Myopic Chinese Children.

Purpose: To compare visual function of myopic children who had worn either defocus incorporated multiple segment (DIMS) spectacle lenses or single vision (SV) spectacle lenses over two years. Methods: We included 160 Chinese myopic (-1 diopter [D] to -5 D) children aged 8 to 13 years in a randomized clinical trial; they wore either DIMS lenses (DIMS; n = 79) or regular SV spectacles lenses (n = 81) full time for 2 years. Visual function, including high-contrast visual acuity (VA) and low-contrast VA at distance and near, binocular functions, and accommodation, before, during, and after 2 years of spectacle wear were assessed when both groups wore SV corrections. Changes of visual function between the two groups and within groups were compared. Results: There were no statistically significant differences in the 2-year visual function changes between DIMS and SV groups (repeated measures analysis of variance with group as factor; P > 0.05). Statistically significant improvement in the best-corrected distance high-contrast VA (P < 0.001) and stereoacuity score (P < 0.001) were found after DIMS lens wear over 2 years. Similar findings were observed after SV spectacle lens wear. For both the DIMS and SV groups, there were statistically significant decreases in accommodative lag, monocular and binocular amplitude of accommodation after two years (P < 0.01), but not in the changes in distance low-contrast VA, near high-contrast VA, near low-contrast VA, or phoria. Conclusions: Although changes in some visual function were shown during 2 years of DIMS lens wear, similar changes were found with SV lens wear. Wear of DIMS spectacle lenses for 2 years does not adversely affect major visual function when children return to SV corrections. Translational Relevance: DIMS spectacle lenses did not cause any adverse effects on visual function.

Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial.

BACKGROUND: Myopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, several publications indicate that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trials have compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses: defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition lenses (PALs). METHODS: The trial is designed as a 3-year, prospective, randomized, multicenter clinical trial of schoolchildren treated with DIMS lenses and PALs. A total of 600 Chinese primary school children aged 6-12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between - 1.00 and - 5.00 diopters and astigmatism ≤ 1.50 diopters. The follow-up time points will be 1 month (m), 3 m, 6 m, 12 m, 18 m, 24 m, 30 m, and 36 m. The primary outcome will be determined by the difference between the two groups in cycloplegic spherical equivalent refraction between baseline and the last follow-up visit. The secondary outcome is the axial length, and the exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, accommodation, compliance, and the results of questionnaires related to wearing experiences. DISCUSSION: The present study will be the first randomized controlled trial in myopic primary school children treated with DIMS lenses and PALs in China. The results will indicate whether and how much different MD mechanisms retard myopia progression and axial elongation. In addition, the comparison will provide information on the clinical efficacy and safety of DIMS lenses and PALs, including information related to wearing experiences and visual function. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900025645. Registered on 3 September 2019. http://www.chictr.org.cn/showproj.aspx?proj=42927.

Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial.

AIM: To determine if 'Defocus Incorporated Multiple Segments' (DIMS) spectacle lenses slow childhood myopia progression. METHODS: A 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. RESULTS: 160 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. CONCLUSIONS: Daily 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.

Inverting peripheral hyperopic defocus into myopic defocus among myopic schoolchildren using addition power of multifocal contact lens.

PURPOSE: The purpose was to determine the minimum near-addition power needed using Proclear® multifocal D-Design contact lens (adds: +1.50 D, +2.50 D, +3.00 D, and +3.50 D) to invert the pattern of relative hyperopic defocus in the peripheral retina into relative myopic defocus among the eyes of myopic schoolchildren. METHODS: Twenty-seven right eyes (24 females and 3 males) of 27 myopic schoolchildren aged between 13 and 15 years were included in this study. The measurements of central refraction, peripheral refraction (between 35° temporal and 35° nasal visual field in 5° steps), and lag of accommodation were conducted using the Grand-Seiko WR-5100K open-field autorefractometer initially without correction (WC), followed by with correction using four different addition powers of Proclear® multifocal D-Design contact lens in random sequence. Axial length was measured using a handheld probe ultrasound A-scan (Tomey AL-2000). RESULTS: The relative peripheral refractive error showed high hyperopic defocus of +1.08 ± 1.24 D at 35° nasal and +1.06 ± 1.06 D at 35° temporal visual field WC. All Proclear multifocal contact lenses (MFCLs) decreased the peripheral hyperopic defocus with increasing addition powers (F [2.938, 47.001] = 13.317, P < 0.001). However, only +3.00 D addition and +3.50 D addition (P = 0.001) could invert the peripheral hyperopic defocus into peripheral myopic defocus. Apart from that, the +3.00 D addition lens showed the lowest lag of accommodation (+1.10 ± 0.83 D) among the other MFCL adds (P = 0.002). CONCLUSION: A +3.00 D addition Proclear MFCL is the optimal addition power that can invert the pattern of peripheral hyperopic defocus into myopic defocus.

A meta-analysis on peripheral defocus soft contact lens controlling myopia progression in children and adolescents / 中华实验眼科杂志

Objective:To evaluate the effect of peripheral defocus soft contact lenses (PDSCLs), single-vision spectacles and single-vision contact lenses (SVCLs) on the progression of myopia in children and adolescents.Methods:A meta-analysis was conducted.To collect relevant studies on the myopia control effect of PDSCLs in children, English databases including PubMed, Medline, Embase and Cochrane library were searched with myopia, contact lens, children, adolescents, myopia progression, axial length, refractive error and relevant free English terms as key words.Chinese databases including CNKI, Wanfang and VIP were searched with corresponding Chinese phrases and relevant free Chinese terms as key words.Randomized controlled trials (RCTs) on the myopia control effect in children and adolescents, with PDSCLs wearer as experimental group and single-vision spectacles or SVCLs wearer as control group, were independently collected by two researchers.Quality of included studies was evaluated with the Cochrane tool to assess risk of bias for RCTs.Combined effects of change in refraction and axial length between experimental and control groups was calculated by weighted mean difference (WMD) and 95%confidence interval ( CI). The heterogeneity of included studies was evaluated by I2 statistic.The refraction and axial length of experimental and control groups were compared by Z test.Myopia control effect of different PDSCLs add powers was analyzed by subgroup analysis.The experimental data with add power ≤+ 2.00 D, low aberration and low depth of focus were assigned to low-medium add power subgroup, and the experimental data with add power >+ 2.00 D, high aberration and high depth of focus were assigned to high add power subgroup. Results:A total of 378 publications were retrieved.Finally, 10 high-quality RCTs and 14 groups of data were included in this meta-analysis.In these studies, 1 645 myopic children aged from 6 to 18 years were enrolled, including 808 cases in experimental group and 837 in control group.The follow-up ranged from 10 to 36 months.Among the 10 studies, there were two crossover trials without a washout period, so only the first intervention results were included.According to the meta-analysis, the change in refraction in experimental group was significantly less than that in control group (WMD=0.22 D, 95% CI: 0.15-0.30, Z=5.65; P<0.05). The change in axial elongation was significantly less in experimental group than control group (WMD=-0.10 mm, 95% CI: -0.12--0.09, Z=12.28; P<0.05). Subgroup analysis showed that the WMD of refraction change and axial elongation between experimental and control groups were 0.21 D (95% CI: 0.10-0.31) and-0.10 mm (95% CI: -0.13-0.08) in the low-medium add power subgroup, respectively, and were 0.26 D (95% CI: 0.13-0.38) and -0.13 mm (95% CI: -0.15--0.10) in the high add power subgroup, respectively. Conclusions:PDSCLs have better myopia control effect than single-vision spectacles and SVCLs in children and adolescents.When the add power is higher, PDSCLs can slow the progression of myopia more effectively.