The SightGlass DOT spectacles lens ARVO 2024 showcase

Authors: Debbie Laughton¹, Jennifer S. Hill¹, Lucill Wang¹, Marcella McParland¹

1. SightGlass Vision Inc, Texas, United States

This research evaluated the effectiveness of Diffusion Optics Technology™ (DOT) spectacle lenses in controlling myopia progression among a Chinese population. In a randomized controlled clinical trial involving 71 myopic children aged 6 to 13 years, DOT lenses were compared to standard single-vision lenses. After 6 months of wearing DOT lenses, the control group showed myopia progression of 0.19 mm in axial length (AL) and -0.38D in cycloplegic spherical equivalent refraction (cSER). In the DOT group there was no significant increase in AL (mean change of -0.05 mm) and a negligible change in cSER (mean change of 0.01D). The mean myopia control effect (DOT–Control) was -0.23mm for AL and 0.39D for cSER. These findings suggest that DOT lenses effectively slowed myopia progression in Chinese children, with this data sitting alongside the multisite RCT from North America to provide evidence supporting the hypothesis of modulating retinal contrast to manage myopia across various ethnicities and in older age groups, with the children up to 13 years of age also included in the study. Comparing results from other recent RCT results can be challenging due to differences in design, participant ethnicity and age groups. However, the data from this trial helps to compare the performance of the DOT lenses with other defocus-based myopia controlling spectacle lenses which also evaluated 100% Asian cohorts. At the 6-month mark, the DOT lenses seem to potentially provide the most promising performance.^1,2

Purpose: Diffusion Optics Technology™ (DOT) spectacle lenses are designed to slow myopia progression by modulating retinal contrast and have demonstrated excellent safety and efficacy in a 4-year clinical trial (CYPRESS) in North America. The purpose of this research was to evaluate the myopia control efficacy of DOT spectacle lenses in a Chinese population.

Methods: Myopic children aged 6 to 13 years were enrolled in a 1-year randomized controlled clinical trial across 5 Chinese sites (NCT05562622). Data from 71 children who had completed the 6-month visit were analysed. Participants were randomised to wear either DOT spectacle lenses or standard single-vision Control spectacle lenses in a 2:1 ratio. The current sample included n=48 (67.6%) DOT lens wearers. The primary endpoints were based on within-subject change from baseline in Axial Length (AL in mm) and cycloplegic Spherical Equivalent Refraction (cSER in Dioptre).

 Results: Participants mean age was 9.87 ± 1.72 years; male n=39, 54.9%. For the Control group (n=23), the mean (SE) AL and cSER increased by 0.19 (0.04) mm (95%CI: [0.11, 0.26], p <0.001) and by -0.38 (0.08) D (95%CI: [-0.54, -0.22], p<0.0001), respectively. In contrast, there was no evidence for similar increases from baseline in the DOT group (n=48), the mean (SE) AL and cSER were -0.05 (0.02) mm (95%CI: [-0.09, 0.00], p=0.04) and 0.01 (0.05) D (95%CI: [-0.10, 0.11], p=0.85), respectively. The unadjusted mean differences (DOT–Control) in the changes from baseline were significant, -0.23 mm (95%CI: [-0.32, -0.14]) for AL and 0.39 D (95%CI: [0.21, 0.58]) for cSER.

 Conclusions: In a Chinese cohort, DOT spectacle lenses significantly slowed myopia progression and axial elongation compared to standard single vision spectacle lenses after 6 months of wear. These results support the hypothesis that modulating retinal contrast can slow myopia progression in children from diverse populations.

Authors: Reena Rani¹, Inderjit Chatha¹, Hiu Yan Lam¹, Nicola S. Logan¹, Amy L. Sheppard¹, James Stuart Wolffsohn¹, Debbie Laughton², Leon N. Davies¹

1. Aston University School of Optometry, Birmingham, Birmingham, United Kingdom
2. SightGlass Vision Inc, Texas, United States

In this study, distance and near visual acuity (VA) with three myopia control spectacle lens designs (2 peripheral defocus designs and 1 contrast modulation design) were tested in high and low contrast conditions. Myopic adults (n=20) were corrected with soft contact lenses and wore four different types of spectacle lenses in plano power: Diffusion Optics Technology (DOT), Defocus Incorporated Multiple Segments (DIMS), Highly Aspherical Lenslets (HAL), and single vision (SV). The results revealed that while central distance VA was equivalent across all lenses for high-contrast letters, central near VA was reduced by 0.06 logMAR (3 letters) in DIMS and 0.05 logMAR (2.5 letters) in HAL compared to SV. When measured through the peripheral treatment zone of the lenses, DOT did not impact VA, while high-contrast VA was reduced at distance and near by DIMS (around 1.5 lines) and HAL (around 0.5-0.8 lines) compared to SV. All myopia control lens designs reduced low-contrast acuity at distance and near through their treatment zones. These evident differences in lens performance should be considered by clinicians in their prescribing choices, particularly with reference to the lifestyle and hobbies of the child, which may influence the experience of different lens types.

Purpose: To profile the immediate effect of spectacle-based myopia management interventions on high- and low-contrast foveal visual acuity (VA) through lens centre and periphery at two distances in adults.

 Methods: Twenty myopic (MSE -4.25D to -0.50D) adults (16F); aged 18-30 years, rendered functionally emmetropic with spherical soft contact lenses wore, sequentially, lenses with Diffusion Optics Technology (DOT), Defocus Incorporated Multiple Segments (DIMS), Highly Aspherical Lenslets (HAL) and single vision (SV) plano spectacle lenses in a prospective, single-visit, double-blind, four-way randomised crossover study. Measures of foveal VA were taken through the lens centre and periphery (decentred 10mm from the optical centre). All participants completed eight monocular tasks: high- (96%) and low-contrast (10%) logMAR foveal VA at distance (4 m) and near (40 cm) through the lens centre and periphery.

 Results: Central- distance VA was similar across all lenses for high- (p=0.06) and low-contrast (p=0.74) letters, whilst central near DIMS lens high-contrast VA reduced by 0.06±0.02 logMAR and HAL low-contrast VA by 0.05±0.01 logMAR compared with SV (both p<0.05). Peripheral - distance high-contrast VA was worse with the DIMS lens than SV (p<0.001), DOT (p<0.001) and HAL lenses (p<0.05). DIMS lens high-contrast VA reduced by 0.16±0.02 logMAR (distance) and 0.13±0.01 logMAR (near) compared with SV. HAL also reduced high-contrast VA versus SV (distance: 0.08±0.019 logMAR, p<0.01; near: 0.05±0.017 logMAR, p<0.05). DOT lenses had no significant impact on distance (p=0.85) or near (p=0.09) high-contrast VA through the peripheral treatment zone. For low-contrast measures, all lenses reduced distance VA [by 0.09 (DOT), 0.12 (HAL) and 0.17 (DIMS) logMAR] and near VA [by 0.11 (DOT), 0.10 (HAL) and 0.14 (DIMS) logMAR] with reference to the SV control (all p<0.001).

 Conclusions: Whilst all three myopia management lenses performed relatively well centrally against a SV comparator, the results suggest wearers’ foveal VA is differentially affected through peripheral treatment zones. Specifically, the results indicate DOT lenses provide superior visual acuity in the treatment zone, equivalent to SV lenses. Clinicians should be aware of these differences in peripheral VA between myopia management lenses, and carefully consider visual requirements when discussing treatment options with patients and carers.

Authors: Leon N. Davies¹, Inderjit Chatha¹, Reena Rani¹, Hiu Yan Lam¹, Nicola S. Logan¹, Amy L. Sheppard¹, James Stuart Wolffsohn¹, Debbie Laughton²

1. School of Optometry, Aston University College of Health and Life Sciences, Birmingham, Birmingham, United Kingdom
2. SightGlass Vision Inc, Texas, United States

Anecdotal reports suggest non-tolerance to myopia control spectacle lenses may occur due to visual issues/interference from the treatment zone optics : this study examined whether these spectacle lenses affect dynamic vision. Twenty myopic adults aged 18 to 30 years underwent dynamic vision testing through the centre and periphery of different lenses: Diffusion Optics Technology (DOT), Defocus Incorporated Multiple Segments (DIMS), Highly Aspherical Lenslets (HAL), and single vision (SV) plano lenses. Results showed that all lenses performed similarly in terms of error score in the Hart Chart test, and task duration in the Circles Search test. Peripheral near acuity threshold (NAT), maximum reading speed (MRS), and critical print size (CPS) were comparable between SV, DOT, and HAL lenses. The DIMS lens had significantly higher NAT and larger CPS compared to SV, DOT, and HAL lenses meaning it detrimentally affected reading vision the most out of all test lenses. Overall, dynamic vision through all three myopia management lenses performed well compared to SV control, but differences in reading performance were observed in the DIMS lens, particularly through the lens periphery. This highlights the need for clinicians to consider the specific visual tasks that patients frequently engage in, such as reading, when recommending myopia management lenses.

Purpose: To explore anecdotal reports of difficulties with dynamic vision whilst wearing defocus-based myopia management spectacle lenses by determining the short-term effect of myopia management spectacle lenses on measures of dynamic vision in adults.

 Methods: Twenty myopic (MSE -4.25D to -0.50D) adults (16F); aged 18 to 30 years, rendered functionally emmetropic with spherical soft contact lenses wore, sequentially, lenses with Diffusion Optics Technology (DOT), Defocus Incorporated Multiple Segments (DIMS), Highly Aspherical Lenslets (HAL) and single vision (SV) plano spectacle lenses in a prospective, single-visit, double-blind, four-way randomised crossover study. To ascertain differential effects of eye gaze, measures of dynamic vision were taken through the lens centre and periphery (decentred 10 mm from the optical centre). Viewed monocularly, participants completed three tasks: 1) Hart Chart dynamic vision test; 2) Circles Search test, and 3) MNRead.

 Results: Using the Hart Chart test, all four lenses were comparable in terms of error score (p=0.53), whilst pairwise comparisons of distance-near cycles per minute were invariant after Bonferroni correction (all p>0.008). Similarly, for task duration, all lenses performed equally well with the Circles Search test through the lens centre (p=0.68) and the lens periphery (p=0.35). Peripheral near acuity threshold (NAT), maximum reading speed (MRS) and critical print size (CPS) were all similar between the SV, DOT and HAL lenses (all p>0.05), with the DIMS lens demonstrating a significantly higher (i.e., worse) NAT (by 0.11 ± 0.02 logMAR compared to SV, p<0.001) and a larger (i.e., worse) CPS than SV (p<0.001), DOT (p<0.01) and HAL (p<0.001) lenses.

 Conclusions: Generally, dynamic vision through all three myopia management lenses performed well compared to the SV control for both the lens centre and periphery. Despite anecdotal reports, the selected tests have not been able to quantify differences in dynamic vision. Clinicians should, however, be cognisant of differences in reading performance between lenses, typically through the lens periphery, and should consider visual requirements when discussing treatment options with parents and children. Further research is required to determine the long-term impact of myopia management interventions on dynamic visual function in children.

Authors: Asiya Jabeen¹, Doerte Luensmann¹, Jill Woods¹, Jennifer S. Hill², Lyndon Jones¹

1. Centre for Ocular Research & Education, University of Waterloo, Waterloo, Ontario, Canada
2. SightGlass Vision Inc, Texas, United States

The choroid is an important biomarker of the eye growth in the human eye.³ This study explored regional changes in choroidal thickness (ChT) after children wore Diffusion Optics Technology™ (DOT) spectacle lenses for short periods. 30 emmetropic children aged 8 to 14 years wore plano DOT spectacle lenses without central apertures, which were compared to +3.00D spectacle lenses (providing a full field of myopic defocus) in a prospective, randomized, subject-masked crossover study. High-resolution OCT measured ChT at the central, parafoveal, and perifoveal regions before and after the participants watched a high-contrast video for intervals of 0, 30, and 60 minutes. Results showed that, compared to the +3.00D lenses, the DOT lenses significantly increased ChT in 4 of 9 macula regions assessed after 30 minutes: these included the central, parafoveal (nasal and temporal), and inferior perifoveal areas. At the 60-minute mark, most regions returned to initial levels except for the lower near-periphery. The results suggest that DOT lenses can induce greater choroidal thickening than +3.00D lenses, demonstrating the choroid’s sensitivity to changes in contrast. The impact of contrast on ChT has not been widely studied, and these findings are promising in showing that the choroid can respond to contrast similarly to defocus. Further research is required to investigate if contrast management can prevent or slow the onset of myopia in emmetropic children, and would help to understand the longer-term influence of contrast on ChT, and how this could be related to myopia control efficacy.

Purpose: To investigate regional changes in choroidal thickness (ChT) following short-term wear of Diffusion Optics Technology™ (DOT) spectacle lenses, designed to control myopia by lowering retinal contrast.

 Methods: Emmetropic children (SER +1.00 to -0.75 D) aged 8 to 14 years wore plano DOT spectacle lenses without central apertures and +3.00D spectacle lenses in a two-visit, prospective, randomized, subject-masked crossover study. High-resolution OCT (Triton DRI-OCT, Topcon) evaluated central, parafoveal (3 mm from the fovea) and perifoveal (6 mm from the fovea) ChT after 0, 30 and 60 minutes of viewing a high contrast video at each visit.

 Results: A total of 30 participants (17F, 13M) with a mean (± SD) age of 10.9 (1.7) years completed the study. After 30 minutes of spectacle lens wear, a significant increase in ChT was observed with DOT spectacle lenses compared to +3.00D spectacle lenses in 4 of the 9 macula regions evaluated (p<0.05 for all). DOT spectacles showed a significant ChT thickening in the central (+7.69 ± 4.19 µm), parafoveal regions at nasal (+9.01 ± 2.77 µm) and temporal (+6.20 ± 5.46 µm) and inferior perifoveal (+9.79 ± 2.31 µm) compared to myopic defocus with +3.00D lenses. After 60 minutes, ChT remained higher only in the inferior parafoveal region (+3.96 ± 8.33 µm, p=0.03), while all other regions returned to baseline levels.

 Conclusions: After short-term DOT spectacle lens wear, emmetropic children experienced macula ChT thickening, similar or greater than the response observed with +3.00D spectacle lens wear. These results indicate the choroid is able to respond to contrast reduction. Further research is required to investigate the long-term impact of contrast modulation on ChT.