Efficacy of Different Powers of Low-Level Red Light in Children for Myopia Control.

PURPOSE: To compare the efficacy and safety of low-level red light (LRL) in controlling myopia progression at 3 different powers: 0.37 mW, 0.60 mW, and 1.20 mW. DESIGN: Single-center, single-masked, randomized controlled trial. PARTICIPANTS: Two hundred children aged 6-15 with myopia of -0.50 diopter (D) or more and astigmatism of -2.50 D or less were enrolled from April to May 2022. Follow-up ended in December 2022. METHODS: Participants were assigned randomly to 3 intervention groups and 1 control group (1:1:1:1). All participants wore single-vision spectacles. Moreover, the intervention group randomly received LRL at 3 different powers twice daily for 3 minutes per session, with a minimum 4-hour interval. MAIN OUTCOME MEASURES: Changes in spherical equivalent (SE), axial length (AL), and subfoveal choroidal thickness (SFCT) were measured. RESULTS: After 6 months, SE progression was significantly lower in the 0.37-mW group (0.01 D; 95% confidence interval [CI], -0.12 to 0.15), 0.60-mW group (-0.05 D; 95% CI, -0.18 to 0.07), and 1.20-mW group (0.16 D; 95% CI, 0.03 to 0.30) compared to the control group (-0.22 D; 95% CI, -0.50 to 0.30; adjusted P < 0.001 for all). AL changes in the 0.37-mW group (0.04 mm; 95% CI, -0.01 to 0.08), 0.60-mW group (0.00 mm; 95% CI, -0.05 to 0.05), and 1.20-mW group (-0.04 mm; 95% CI, -0.08 to 0.01) were significantly smaller than the control group (0.27 mm; 95% CI, 0.22 to 0.33; adjusted P < 0.001 for all). Similarly, increases in SFCT were significantly greater in the 0.37-mW group (22.63 µm; 95% CI, 12.13 to 33.34 µm), 0.60-mW group (36.17 µm; 95% CI, 24.37 to 48.25 µm), and 1.20-mW group (42.59 µm; 95% CI, 23.43 to 66.24 µm) than the control group (-5.07 µm; 95% CI, -10.32 to -0.13 µm; adjusted P < 0.001 for all). No adverse events were observed. CONCLUSIONS: LRL effectively controlled myopia progression at 0.37 mW, 0.60 mW, and 1.20 mW. Further research is required. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Myopia Control Effect of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology: A Multicenter Randomized Controlled Trial.

PURPOSE: To investigate the efficacy and safety of repeated low-level red-light (RLRL) therapy combined with orthokeratology among children who, despite undergoing orthokeratology, exhibited an axial elongation of at least 0.50 mm over 1 year. DESIGN: Multicenter, randomized, parallel-group, single-blind clinical trial (ClinicaTrials.gov identifier, NCT04722874). PARTICIPANTS: Eligible children were 8-13 years of age with a cycloplegic spherical equivalent refraction of -1.00 to -5.00 diopters at the initial orthokeratology fitting examination and had annual axial length (AL) elongation of ≥0.50 mm despite undergoing orthokeratology. Forty-eight children were enrolled from March 2021 through January 2022, and the final follow-up was completed in March 2023. METHODS: Children were assigned randomly to the RLRL therapy combined with orthokeratology (RCO) group or to the orthokeratology group in a 2:1 ratio. The orthokeratology group wore orthokeratology lenses for at least 8 hours per night, whereas the RCO group received daily RLRL therapy twice daily for 3 minutes in addition to orthokeratology. MAIN OUTCOME MEASURES: The primary outcome was AL change measured at 12 months relative to baseline. The primary analysis was conducted in children who received the assigned intervention and completed at least 1 follow-up after randomization using the modified intention-to-treat principle. RESULTS: Forty-seven children (97.9%) were included in the analysis (30 in the RCO group and 17 in the orthokeratology group). The mean axial elongation rate before the trial was 0.60 mm/year and 0.61 mm/year in the RCO and orthokeratology groups, respectively. After 12 months, the adjusted mean AL changes were -0.02 mm (95% confidence interval [CI], -0.08 to +0.03 mm) in the RCO group and 0.27 mm (95% CI, 0.19-0.34 mm) in the orthokeratology group. The adjusted mean difference in AL change was -0.29 mm (95% CI, -0.44 to -0.14 mm) between the groups. The percentage of children achieving an uncorrected visual acuity of more than 20/25 was similar in the RCO (64.3%) and orthokeratology (65.5%) groups (P = 0.937). CONCLUSIONS: Combining RLRL therapy with orthokeratology may offer a promising approach to optimize axial elongation control among children with myopia. This approach also potentially allows children to achieve satisfactory visual acuity, reducing daytime dependence on corrective eyewear. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Novel Lenslet-ARray-Integrated Spectacle Lenses for Myopia Control: A 1-Year Randomized, Double-Masked, Controlled Trial.

PURPOSE: To investigate the myopia control efficacy of novel Lenslet-ARray-Integrated (LARI) spectacle lenses with positive power lenslets (PLARI) and negative power lenslets (NLARI) worn for 1 year in myopic children. DESIGN: Randomized, double-masked, controlled clinical trial. PARTICIPANTS: A total of 240 children 6 to 12 years of age with spherical equivalent refraction (SER) between -4.00 and -1.00 diopters (D), astigmatism of ≤ 1.50 D, and anisometropia of ≤ 1.00 D. METHODS: Participants were assigned randomly in a 1:1:1 ratio to PLARI, NLARI, and 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, and -0.66 ± 0.40 D, respectively; AE: 0.19 ± 0.20 mm, 0.17 ± 0.14 mm, 0.34 ± 0.18 mm, respectively; all P < 0.001). No significant differences were found 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 group (r = 0.40 [P < 0.001] and r = -0.59 [P < 0.001], respectively) and PLARI group (r = 0.46 [P < 0.001] and r = -0.52 [P < 0.001], respectively), 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 AE. Faster myopia progression, in terms of both SER and AE, was associated with younger age in the SV and PLARI groups but not the NLARI group. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Study of association between corneal shape parameters and axial length elongation during orthokeratology using image-pro plus software.

BACKGROUND: The aim was to validate the correlation between corneal shape parameters and axial length growth (ALG) during orthokeratology using Image-Pro Plus (IPP) 6.0 software. METHODS: This retrospective study used medical records of myopic children aged 8-13 years (n = 104) undergoing orthokeratology. Their corneal topography and axial length were measured at baseline and subsequent follow-ups after lens wear. Corneal shape parameters, including the treatment zone (TZ) area, TZ diameter, TZ fractal dimension, TZ radius ratio, eccentric distance, pupil area, and pupillary peripheral steepened zone(PSZ) area, were measured using IPP software. The impact of corneal shape parameters at 3 months post-orthokeratology visit on 1.5-year ALG was evaluated using multivariate linear regression analysis. RESULTS: ALG exhibited significant associations with age, TZ area, TZ diameter, TZ fractal dimension, and eccentric distance on univariate linear regression analysis. Multivariate regression analysis identified age, TZ area, and eccentric distance as significantly correlated with ALG (all P < 0.01), with eccentric distance showing the strongest correlation (ß = -0.370). The regressive equation was y = 1.870 - 0.235a + 0.276b - 0.370c, where y represents ALG, a represents age, b represents TZ area, and c represents eccentric distance; R2 = 0.27). No significant relationships were observed between the TZ radius ratio, pupillary PSZ area, and ALG. CONCLUSIONS: IPP software proves effective in capturing precise corneal shape parameters after orthokeratology. Eccentric distance, rather than age or the TZ area, significantly influences ALG retardation.

Effect of virtual reality-based visual training for myopia control in children: a randomized controlled trial.

BACKGROUND: To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children. METHODS: The randomized, parallel-group, single-blind clinical trial conducted at the Department of Ophthalmology of Shanghai Tenth People's Hospital enrolled 65 low-myopic children (aged 8 to 13 years) with cycloplegic spherical equivalent (SE) between - 0.50 and - 3.00 diopters (D), astigmatism less than - 1.00 D, anisometropia less than 1.50D, and best corrected visual acuity (BCVA) more than 0.0 logarithm (LogMAR) of the minimum angle of resolution. The participants were enrolled in December 2020, and the follow-up of this study concluded on August 2021. Children were assigned randomly to the intervention group (VRVT plus single-vision spectacle [SVS]) and the control group (only SVS without receiving VRVT). The intervention group was administered for 20 min per day with VRVT under parental supervision at home. The primary outcome was changes in axial length (AL) at 3 months. Macular choroidal thickness (mCT) was regarded as a key secondary outcome. RESULTS: Among 65 participants (mean age: 10.8 years, 52.3% male), 60 children (92.3%) who completed the 3-month intervention and 6-month follow-up were included in the analysis (30 in the intervention group and 30 in the control group). The changes of AL were 0.063 ± 0.060 mm (95% confidence interval [CI], 0.074 to 0.119 mm) in the intervention group and 0.129 ± 0.060 mm (95% CI, 0.107 to 0.152 mm) and in the control group at 3 months (t = - 2.135, P = 0.037), and the mean difference between the two groups was 0.066 mm. The change of mCT were 22.633 ± 36.171 µm (95% CI, 9.127 to 36.140 µm) in the intervention group and - 3.000 ± 31.056 µm (95% CI, - 14.597 to 8.597 µm) in the control group at 3 months (t = 2.945, P = 0.005). VR vertigo was the most common adverse event which was occurred in two children (2/30, 6.67%) in the intervention group. CONCLUSIONS: VRVT is a promising method for myopia control in children with good user acceptability. Among children aged 8 to 13 years with low-myopia, nightly use of VRVT resulted in slowing myopia progression. TRIAL REGISTRATION: This protocol was registered with ClinicalTrials.gov (NCT06250920), retrospectively registered on 01 February 2024.

Peripheral refraction under different levels of illuminance.

Peripheral refraction is believed to be involved in the development of myopia. The aim of this study was to compare the relative peripheral refraction (RPR) at four different levels of illuminance, ranging from photopic conditions to complete darkness, using an open-field autorefraction method. The RPR was calculated for each eccentricity by subtracting central from peripheral autorefraction measurements. The study included 114 myopic eyes from 114 subjects (mean age of 21.81 ± 1.91 years) and the mean difference in RPR between scotopic and photopic conditions (0 and 300 lux, respectively) was +0.32 D at 30° temporal and +0.37 D at 30° in the nasal visual field (NVF). Statistically significant differences were observed between 0 and 300 lux at 30° in the temporal visual field and at 30° and 20° in the NVF. Our results revealed a significant increase in relative peripheral hyperopia with increasing visual field eccentricity along the horizontal visual field in myopic eyes of young adults. Furthermore, this relative peripheral hyperopia increased as illumination decreased. These findings suggest that an increase in peripheral illuminance may protect against myopic eye growth.

Retinal shadows produced by myopia control spectacles.

PURPOSE: To analyse ocular coherence tomography (OCT) images of the retinal shadows caused by defocus and diffusion optics spectacles. METHODS: One eye was fitted successively with the Hoya Defocus Incorporated Multiple Segments (DIMS) spectacle lens, two variations of the +3.50 D peripheral add spectacle (DEFOCUS) and the low-contrast dot lens (Diffusion Optics Multiple Segments, DOMS); each at a vertex distance of 12 mm. Simultaneously, a retinal image of the macular region with central fixation was obtained using infrared OCT. The corneal power and intraocular distances were determined using an optical biometer. RESULTS: The retinal images for the DIMS and DOMS lenses showed patterns of obvious retinal shadows in the periphery, while the central 10-11° remained clear. The DEFOCUS lens produced a darkened peripheral area. Dividing the size of the retinal pattern, measured with the calliper of the OCT software, by the actual size on the spectacle lens gave a magnification of -0.57 times. This is consistent with the incoming OCT beam being imaged to a position approximately 31 mm beyond the front of the eye. [Correction added on 26 October 2023 after first online publication: The preceding paragraph was corrected.] CONCLUSION: With device-specific correction, retinal OCT images can help visualise the regions affected by the defocus or lowered contrast induced by myopia control spectacles. This is of potential value for improving myopia therapies.

Eye growth pattern of myopic children wearing spectacle lenses with aspherical lenslets compared with non-myopic children.

INTRODUCTION: To evaluate eye growth of children wearing spectacle lenses with highly aspherical lenslets (HAL), slightly aspherical lenslets (SAL) and single-vision lenses (SVL) compared to eye growth patterns in non-myopes in Wenzhou, China. METHODS: The randomised trial had 170 myopic children (aged 8-13 years) randomly assigned to the HAL, SAL or SVL group. Normal eye growth was examined using 700 non-myopic schoolchildren (aged 7-9 years) in the Wenzhou Medical University-Essilor Progression and Onset of Myopia (WEPrOM) cohort study using logistic function models. Slow, normal and fast eye growth was defined as range of values <25th, 25th-75th and >75th percentiles, respectively. RESULTS: The predicted upper limits of slow eye growth (25th percentile) among non-myopes aged 7-10 years and 11-13 years were 0.20-0.13 and 0.08-0.01 mm (after 2-year period; 0.37-0.33 and 0.29-0.14 mm), respectively, while the upper limits of normal eye growth (75th percentile) were 0.32-0.31 and 0.28-0.10 mm (after 2-year period; 0.58-0.55 and 0.50-0.24 mm), respectively. The 2-year trial had 157 children, 96 of whom wore their lenses full time (everyday ≥12 h/day). The mean 2-year axial length change for HAL, SAL and SVL was 0.34, 0.51 and 0.69 mm (0.28, 0.46 and 0.69 mm in full-time wear), respectively. Slow eye growth was found in 35%, 17% and 2% (44%, 29% and 3% in full-time wear); normal eye growth in 35%, 26% and 12% (44%, 32% and 9% in full-time wear) and fast eye growth in 30%, 57% and 86% (12%, 39% and 88% in full-time wear), respectively (p < 0.001). CONCLUSIONS: The eye growth pattern in approximately 90% wearing HAL full time (compared with about 10% wearing SVL full time) was similar or slower than that of non-myopic children both after 1- and 2-year periods.

Red light instruments for myopia exceed safety limits.

PURPOSE: Low-level red light (LLRL) therapy has recently emerged as a myopia treatment in children, with several studies reporting significant reduction in axial elongation and myopia progression. The goal of this study was to characterise the output and determine the thermal and photochemical maximum permissible exposure (MPE) of LLRL devices for myopia control. METHODS: Two LLRL devices, a Sky-n1201a and a Future Vision, were examined. Optical power measurements were made using an integrating sphere radiometer through a 7-mm diameter aperture, in accordance with ANSI Z136.1-2014, sections 3.2.3-3.2.4. Retinal spot sizes of the devices were obtained using a model eye and high-resolution beam profiler. Corneal irradiance, retinal irradiance and MPE were calculated for an eye positioned at the oculars of each device. RESULTS: Both devices were confirmed to be Class 1 laser products. Findings showed that the Sky-n1201a delivers laser light as a point source with a 654-nm wavelength, 0.2 mW power (Ø 7 mm aperture, 10-cm distance), 1.17 mW/cm2 corneal irradiance and 7.2 W/cm2 retinal irradiance (Ø 2 mm pupil). The MPE for photochemical damage is 0.55-7.0 s for 2-7 mm pupils and for thermal damage is 0.41-10 s for 4.25-7 mm pupils. Future Vision delivers the laser as an extended source subtending 0.75 × 0.325°. It has a 652-nm wavelength, 0.06 mW power (Ø 7 mm aperture, 10 cm distance), 0.624 mW/cm2 corneal irradiance and 0.08 W/cm2 retinal irradiance (Ø 2 mm pupil). MPE for photochemical damage is 50-625 s for 2-7 mm pupils. DISCUSSION: For both of the LLRL devices evaluated here, 3 min of continuous viewing approached or surpassed the MPE, putting the retina at risk of photochemical and thermal damage. Clinicians should be cautious with the use of LLRL therapy for myopia in children until safety standards can be confirmed.

Can we really distinguish 'responders' from 'non-responders' to myopia control interventions?

PURPOSE: It is common to hear talk of 'responders' and 'non-responders' with respect to myopia control interventions. We consider the reality of distinguishing these sub-groups using data from the first year of the Low-concentration Atropine for Myopia Progression (LAMP) study. METHODS: The first year of the LAMP study was a robustly designed, placebo-controlled trial of three different low concentrations of atropine using a large sample size (N > 100 randomised to each group). The authors subsequently published mean axial elongation and myopia progression rates by age group. We used these data to calculate efficacy in terms of both absolute reduction in myopic progression and absolute reduction in axial elongation for each of the different atropine concentrations at each age group. We then compared these efficacy data to the overall progression for each of the two progression metrics. RESULTS: Plotting efficacy as a function of overall myopia progression and axial elongation for each of the different atropine concentrations demonstrates the invariant nature of efficacy, in terms of clinically meaningful reduction in progression, despite a substantial range of underlying overall progression. That is, faster progressors-the so-called non-responders-achieved similar reduction in axial elongation and myopia progression as the slower progressors-the so-called responders-within the various atropine treatment groups. CONCLUSION: The use of the terms, responders and non-responders, during myopia progression interventions is not supported by evidence. Those designated as such may simply be slower or faster progressors, who, on average achieve the same benefit from treatment.

On-eye centration of soft contact lenses.

PURPOSE: To evaluate the relative positions of modern soft contact lenses (SCLs) relative to the limbus/cornea and the pupil. METHODS: Sixty images of the anterior eyes of 101 subjects were acquired over 10 s while participants fixated the centre of the camera lens located 33 cm in front of the eye in a well-lit (300 lux) clinic. Custom validated image analysis software was used to locate the boundaries of the contact lenses, pupils and corneas (limbus). Horizontal and vertical relative positions of the contact lens, pupil and limbus were calculated from the fitted boundaries. RESULTS: The mean (standard deviation) pupil and corneal diameters for all subjects were 3.84 mm, (0.83) and 11.97 mm (0.48), respectively. The mean [95% confidence interval] pupil centre was located 0.28 mm [0.26, 0.30] nasally and 0.07 mm [0.05, 0.10] superiorly to the corneal centre. Consistent with clinical observations, the contact lenses centred accurately relative to the corneal centre both nasally 0.04 mm [0.01, 0.07] and inferiorly -0.01 mm [-0.06, 0.03]. However, regardless of the eye, the contact lens was significantly (p < 0.001) decentred relative to the pupil centre both temporally -0.23 mm [-0.26, -0.20] and inferiorly -0.08 mm [-0.12, -0.04]. Decentration magnitudes were significantly correlated between the right and left eyes. CONCLUSIONS: Spherical SCLs centred well on the cornea but temporally and inferiorly from the primary line of sight (pupil centre), due to the differences in the location of the pupil and corneal centres. Contrary to some previous reports, there was no evidence that lens optics or material affected lens centration significantly.

High myopia: Reviews of myopia control strategies and myopia complications.

BACKGROUND: Myopia and especially high myopia are recognised as major public health concerns. Although the prevalence of high myopia in young children is low, 10-20% of high school children in Asia have high myopia, with many still progressing, and one in three patients with high myopia develop visual impairment with age. Most participants in myopia control studies have low and moderate myopia; relatively little is known about myopia control in high myopia. METHOD: Literature searches were undertaken in MEDLINE and EMBASE to identify publications in English, investigating (Aim 1) the efficacy of myopia control strategies (environmental, pharmacological and optical) in high myopia (≤-6.00 D) and (Aim 2) the complications of high myopia using keywords. Outcomes included change in spherical equivalent refractive error (SE) and/or axial length (AL) to evaluate progression in high myopia. RESULTS: Aim 1: Twelve studies were identified that reported the efficacy of optical and pharmacological (none on environmental) interventions on AL and SE for high myopia control. A statistically significant reduction in progression of SE and AL in high myopes was reported with 1% and 0.5% atropine. Defocus Incorporated Multiple Segment spectacle lenses had lower efficacy in slowing high myopia progression compared to moderate and low myopia. Ortho-K lenses were equally effective in reducing myopia progression in low, moderate and high myopia. Aim 2: Myopic patients have an increased risk of myopic macular degeneration, retinal detachment, cataract and glaucoma, with the risk increasing with the level of myopia. CONCLUSIONS: High myopia has significant effects on quality of life, risk of pathological complications and vision impairment. Young children, excluding those with some syndromic associations, who are fast progressing moderate and high myopes require early intervention and close monitoring. Further research investigating the efficacy of myopia control strategies in highly myopic patients, both independently and through combination treatments, are necessary.

Refractive power profiles of commercially available soft multifocal contact lenses for myopia control.

PURPOSE: Lens power profiles can provide valuable insights on the imposed optical defocus and visual experience of contact lens wearers, especially in the context of myopia control. This study measured the refractive power profiles of multifocal soft contact lenses (MFCLs) currently used or that have the potential for use in myopia control using high spatial resolution aberrometry. The instrument's repeatability for determining MFCLs power profiles was also assessed. METHOD: The power profiles of 10 MFCLs of various designs (centre-distance, centre-near and extended depth of focus) were measured using the Lambda-X NIMOEVO, a phase shifting Schlieren-based device. Power profiles were graphically expressed as measured power at each chord position and the maximum add power was calculated. The repeatability of the NIMOEVO was expressed as the within-subject standard deviation at each chord position for a subset of five MFCLs. RESULTS: The measured distance powers differed from nominal powers for more than half of the MFCLs with a definable distance zone. There were variations in the chord position of the distance and near correction zones, rate of power transitions and calculated maximum add between the MFCLs which did not depend on lens design. For half of the MFCLs, the power profile shape was inconsistent between different nominal back vertex powers of the same design. The repeatability of the NIMOEVO was dependent on the lens design, with designs featuring faster rates of power change exhibiting worse repeatability. CONCLUSIONS: Significant differences in MFCL power profiles were found which were not adequately represented in labelling. This is likely due to the small number of parameters used to define lens power characteristics. Eye health care practitioners should be aware of potential differences in power profiles between different MFCLs, which will impact the retinal defocus introduced during lens wear and the wearer's visual experience.

Effect of myopia-control lenses on central and peripheral visual performance in myopic children.

PURPOSE: To evaluate the short-term effects of three myopia-control lenses, which impose peripheral myopic defocus while providing clear central vision, on central and peripheral visual performance in myopic children. METHODS: Twenty-one myopic children were enrolled in the study. Central visual performance was assessed using the quick contrast sensitivity function. Peripheral visual performance was evaluated by measuring peripheral contrast threshold and global motion perception, while subjects maintained fixation through the central portion of the lens. Single-vision spectacle lenses (SVL), spectacle lenses with highly aspherical lenslets (HAL) and defocus-incorporated soft contact (DISC) lenses were evaluated in random order, followed by orthokeratology (OK) lenses. All tests were performed monocularly on the right eye. RESULTS: The area under the log contrast sensitivity function (AULCSF) with DISC lenses was lower than that with SVL (1.14 vs. 1.40, p < 0.001) and HAL (1.14 vs. 1.33, p = 0.001). HAL increased the temporal visual field contrast threshold compared with OK lenses (p = 0.04), and OK lenses decreased the superior visual field contrast threshold compared with that of SVL (p = 0.04) and HAL (p = 0.005). HAL also increased the peripheral coherence threshold for identifying the contraction movement compared with OK lenses (p = 0.01). CONCLUSIONS: The short-term use of these optical interventions for myopia control exhibited measurable differences in central and peripheral visual performance. Relevant attention could be paid to these differences, especially when children switch to different treatments. DISC lenses exhibited worse central contrast sensitivity than SVL and HAL. Imposing peripheral defocus signals did not affect children's peripheral visual performance compared with SVL. However, considering the poorer peripheral visual performance provided by HAL, OK lenses are recommended for children if there are specific demands for global scene recognition and motion perception.

Six-year cumulative treatment effect and treatment efficacy of a dual focus myopia control contact lens.

PURPOSE: Accumulated axial growth observed during a 6-year clinical trial of a dual focus myopia control contact lens was used to explore different approaches to assess treatment efficacy. METHODS: Axial length measurements from 170 eyes in a 6-year clinical trial of a dual focus myopia control lens (MiSight 1 day, CooperVision) were analysed. Treatment groups comprised one having undergone 6 years of treatment and the other (the initial control group) having 3 years of treatment after 3 years of wearing a single vision control lens. Efficacy was assessed by comparing accumulated ocular growth during treatment to that expected of untreated myopic and emmetropic eyes. The impact of treatment on delaying axial growth was quantified by comparing the increased time required to reach criterion growths for treated eyes and survivor analysis approaches. RESULTS: When compared to the predicted accumulated growth of untreated eyes, 6 years of treatment reduced growth by 0.52 mm, while 3 years of treatment initiated 3 years later reduced growth by 0.19 mm. Accumulated differences between the growth of treated and untreated myopic eyes ranged between 67% and 52% of the untreated myopic growth, and between 112% and 86% of the predicted difference in growth between untreated myopic and age-matched emmetropic eyes. Treated eyes took almost 4 years longer to reach their final accumulated growth than untreated eyes. Treatment increased the time to reach criterion growths by 2.3-2.7 times. CONCLUSION: Estimated growth of age-matched emmetropic and untreated myopic eyes provided evidence of an accumulated slowing in axial elongation of 0.52 mm over 6 years, and the treated growth remained close to that expected of emmetropic eyes. Six years of dual focus myopia control delayed the time to reach the final growth level by almost 4 years.

The effect of individualized ocular refraction customized spectacle lenses on myopia control in schoolchildren: A 1-year randomised clinical trial.

PURPOSE: The aim of this study was to investigate the effect of individualized ocular refraction customized (IORC) spectacle lenses with different actual amounts of peripheral myopic defocus (MD) on myopia control over 1 year. These lenses compensate for the original peripheral refraction via the free-form surface on the back of the lens. METHODS: This 1-year, double-masked randomised clinical trial included 184 myopic schoolchildren aged 8-12 years. Participants were randomised to receive IORC lenses with high (IORC-H group, +4.50 D), medium (IORC-M group, +3.50 D) or low (IORC-L group, +2.50 D) MD or single-vision (SV) lenses. The spherical equivalent refractive error (SER) and axial length (AL) were measured at baseline and 6-monthly intervals. RESULTS: After 1 year, the mean (SD) changes in SER were -0.18 (0.37), -0.36 (0.37), -0.52 (0.39) and -0.60 (0.42) D for the IORC-H, IORC-M, IORC-L and SV groups, respectively. Compared with the SV group, the effects of slowing myopia progression were 70%, 40% and 13% for the IORC-H (difference of 0.47 D, p < 0.001), IORC-M (difference of 0.32 D, p = 0.001) and IORC-L (difference of 0.15 D, p > 0.05) groups, respectively. The mean (SD) changes in AL were 0.12 (0.16), 0.23 (0.17), 0.29 (0.17) and 0.36 (0.17) mm for the IORC-H, IORC-M, IORC-L and SV groups, respectively. The axial elongation was 67%, 36% and 19% lower in the IORC-H (difference of 0.25 mm, p < 0.001), IORC-M (difference of 0.15 mm, p < 0.001) and IORC-L (difference of 0.10 mm, p = 0.04) groups, respectively, compared with the SV group. The IORC-H group exhibited significantly less axial elongation than the IORC-M and IORC-L groups (p = 0.01 and p < 0.001, respectively). CONCLUSION: Compared with the IORC-M and IORC-L lenses, the IORC-H lens was found to have superior efficacy in inhibiting myopic progression and slowing eye growth in schoolchildren, with better myopia control efficacy in younger children.

Anisomyopia and orthokeratology for myopia control - Axial elongation and relative peripheral refraction.

PURPOSE: To investigate axial elongation (AE) and changes in relative peripheral refraction (RPR) in anisomyopic children undergoing orthokeratology (ortho-k). METHODS: Bilateral anisomyopic children, 7-12 years of age, were treated with ortho-k. Axial length (AL) and RPR, from 30° nasal (N30°) to 30° temporal (T30°), were measured at baseline and every 6 months over the study period. AE, changes in RPR and changes in the interocular AL difference were determined over time. RESULTS: Twenty-six of the 33 subjects completed the 2-year study. The AE of the higher myopic (HM) eyes (at least 1.50 D more myopia than the other eye) (0.26 ± 0.29 mm) was significantly smaller than for the less myopic (LM) eyes (0.50 ± 0.27 mm; p = 0.003), leading to a reduction in the interocular difference in AL (p = 0.001). Baseline RPR measurements in the HM eyes were relatively more hyperopic at T30°, N20° and N30° (p ≤ 0.02) and greater myopic shifts were observed at T20° (p < 0.001), T30° (p < 0.001), N20° (p = 0.02) and N30° (p = 0.01) after lens wear. After 2 years of ortho-k lens wear, temporal-nasal asymmetry increased significantly, being more myopic at the temporal locations in both eyes (p < 0.001), while AE was associated with the change in RPR at N20° (ß = 0.134, p = 0.01). The interocular difference in AE was also positively associated with the interocular difference in RPR change at N30° (ß = 0.111, p = 0.02). CONCLUSIONS: Ortho-k slowed AE in bilateral anisomyopia, with slower growth in the HM eyes leading to a reduction in interocular AL differences. After ortho-k, RPR changed from hyperopia to myopia, with greater changes induced in the HM eyes, and slower AE was associated with a more myopic shift in RPR, especially in the nasal field of both eyes.

Visual impact of diffusion optic technology lenses for myopia control.

PURPOSE: To assess the visual impact of Diffusion Optics Technology™ 0.2 DOT lenses (SightGlass Vision Inc.) designed for myopia control on primary gaze. DOT spectacle lenses contain light scattering elements that scatter light as it passes through the lens which, in turn, reduces retinal image contrast. METHODS: Fifty-one children (12.2 ± 1.3, range 10-14 years; 51% females) were randomly assigned to wear DOT spectacle (n = 27) or single vision lenses (n = 24) across six investigational sites in North America. Binocular high- and low-contrast distant visual acuities, near visual acuity, reading speed, contrast sensitivity, stereoacuity and glare were assessed in primary gaze after at least 3 years of wear, with the study 95% powered in all metrics to detect significant differences between the groups. RESULTS: Mean binocular distance high-contrast (-0.09 ± 0.02 vs. -0.08 ± 0.02 logMAR, p = 0.81), low-contrast (0.05 ± 0.02 vs. 0.07 ± 0.02 logMAR, p = 0.52) and near visual acuity with glare sources (-0.06 ± 0.03 vs. -0.09 ± 0.03 logMAR, p = 0.32) were similar for DOT and single vision lens wearers, respectively. Contrast sensitivity was similar between children wearing DOT or single vision lenses across 11 of the 16 spatial frequencies (p > 0.05). Mean stereopsis was similar (p = 0.30) with the DOT lenses (33.2 ± 12.5″) and single vision lenses (38.1 ± 14.2″). Functional reading speed metrics were similar in both study groups, as was the objectively measured head tilt during reading (p > 0.05). The mean halo radius was 0.56° ± 0.17° with the DOT lenses compared with 0.50° ± 0.12° with single vision lenses (p = 0.02), but the statistically significant difference was smaller than the non-inferiority bound of 0.4°. CONCLUSION: Diffusion optics technology lenses provide a clinically equivalent visual experience to a standard single vision lens.

Myopia progression following 0.01% atropine cessation in Australian children: Findings from the Western Australia - Atropine for the Treatment of Myopia (WA-ATOM) study.

BACKGROUND: A rebound in myopia progression following cessation of atropine eyedrops has been reported, yet there is limited data on the effects of stopping 0.01% atropine compared to placebo control. This study tested the hypothesis that there is minimal rebound myopia progression after cessation of 0.01% atropine eyedrops, compared to a placebo. METHODS: Children with myopia (n = 153) were randomised to receive 0.01% atropine eyedrops or a placebo (2:1 ratio) daily at bedtime during the 2-year treatment phase of the study. In the third year (wash-out phase), all participants ceased eyedrop instillation. Participants underwent an eye examination every 6 months, including measurements of spherical equivalent (SphE) after cycloplegia and axial length (AL). Changes in the SphE and AL during the wash-out phase and throughout the 3 years of the study (treatment + wash-out phase) were compared between the treatment and control groups. RESULTS: During the 1-year wash-out phase, SphE and AL progressed by -0.41D (95% CI = -0.33 to -0.22) and +0.20 mm (95% CI = -0.46 to -0.36) in the treatment group compared to -0.28D (95% CI = 0.11 to 0.16) and +0.13 mm (95% CI = 0.18 to 0.21) in the control group. Progression in the treatment group was significantly faster than in the control group (p = 0.016 for SphE and <0.001 for AL). Over the 3-year study period, the cumulative myopia progression was similar between the atropine and the control groups. CONCLUSIONS: These findings showed evidence of rapid myopia progression following cessation of 0.01% atropine. Further investigations are warranted to ascertain the long-term effects of atropine eyedrops.

Myopia Control in Caucasian Children with 0.01% Atropine Eye Drops: 1-Year Follow-Up Study.

Background and Objectives: Myopia is the most widespread ocular disorder globally and its prevalence has been increasing over the past decades. Atropine eye drops stand out as the only pharmacological intervention used in clinical practice to control myopia progression. The aim of this study was to explore the effect of 0.01% atropine eye drops on myopia progression. Patients and Methods: Healthy children aged 6-12 years with cycloplegic spherical equivalent (SE) from -0.5 D to -5.0 D and astigmatism ≤1.5 D were included. Myopia progression was assessed by changes in SE and axial length (AL) over 1 year and SE changes 1 year before the study enrollment and during the 1-year follow-up. Adverse events were evaluated based on complaints reported by either parents or the children themselves during follow-up visits. Results: The analysis involved 55 patients in the 0.01% atropine eye drops group and 66 in the control group. After the 1-year follow-up, the change in SE was -0.50 (-2.25-0.50) D in the control group compared to -0.50 (-1.50-0.50) D in the 0.01% atropine group (p = 0.935); AL change was 0.31 (0.18) mm in the control group and 0.29 (0.18) mm in the 0.01% atropine group (p = 0.480). The change in SE was -0.68 (-2.0--0.25) D/year before the study and remained similar -0.50 (-2.25-0.25) D over the 1-year follow-up in the control group (p = 0.111); SE change was reduced from -1.01 (-2.0--0.25) D/year before the study to -0.50 (-1.5-0.5) D over the 1-year follow-up in the 0.01% atropine group (p < 0.001). In the 0.01% atropine group, ten (16.4%) children experienced mild adverse events, including blurred near vision, ocular discomfort, photophobia, dry eyes, and anisocoria. Conclusions: Compared to the control group, the administration of 0.01% atropine eye drops demonstrated no significant effect on changes in SE and AL over a 1-year follow-up. However, children in the 0.01% atropine group initially experienced higher myopia progression, which decreased with treatment over the course of 1 year. Future studies should explore the long-term effects, rebound effects, potential genetic associations, and efficacy of higher doses of atropine in managing myopia progression.