目的:评估扩散光学技术™0.2DOT镜片(SightGlassVisionInc.)设计用于控制主要注视近视的视觉效果。DOT眼镜镜片包含光散射元件,当光线穿过镜片时,反过来,降低视网膜图像对比度。
方法:51名儿童(12.2±1.3,范围10-14岁;51%的女性)被随机分配到北美六个调查地点的DOT眼镜(n=27)或单视力镜片(n=24)。双目高对比度和低对比度远距视力,接近视力,阅读速度,对比敏感度,佩戴至少3年后,在初次凝视中评估立体敏锐度和眩光,该研究在所有指标中都有95%的供电能力,以检测组间的显著差异。
结果:平均双眼距离高对比度(-0.09±0.02vs.-0.08±0.02logMAR,p=0.81),低对比度(0.05±0.02vs.0.07±0.02logMAR,p=0.52)和近视力与眩光源(-0.06±0.03vs.-0.09±0.03logMAR,p=0.32)对于DOT和单视镜片佩戴者来说是相似的,分别。在16个空间频率中的11个,佩戴DOT或单眼镜片的儿童的对比敏感度相似(p>0.05)。平均立体视觉与DOT镜片(33.2±12.5英寸)和单视觉镜片(38.1±14.2英寸)相似(p=0.30)。两个研究组的功能阅读速度指标相似,阅读过程中客观测量的头部倾斜也是如此(p>0.05)。DOT镜片的平均光晕半径为0.56°±0.17°,而单视镜片的平均光晕半径为0.50°±0.12°(p=0.02),但统计学上的显著差异小于0.4°的非劣效性界限。
结论:扩散光学技术镜片提供了与标准单视觉镜片相当的临床视觉体验。
OBJECTIVE: 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°.
CONCLUSIONS: Diffusion optics technology lenses provide a clinically equivalent visual experience to a standard single vision lens.