Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2024
Visual impact of diffusion optic technology lenses for myopia control.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Wolffsohn James S, Hill Jennifer S, Hunt Chris, Young Graeme
Аннотация
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.
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.