目的:比较使用基于双眼眼睛追踪的新型家庭治疗后的视觉结果(CureSight;NovaSight,Ltd)带补丁。
方法:前瞻性,多中心,随机化,蒙面,控制,非劣效性关键试验。
方法:13名4至9岁屈光参差儿童,小角度斜视性或混合机制性弱视以1:1随机分为CureSight治疗或修补.
方法:CureSight治疗使用组合的立体镜眼镜和眼动追踪器,在双目流媒体视频内容中诱导同眼中央凹周围的实时模糊。参与者每天使用该设备90分钟,5天/周16周(120小时)。修补组接受2小时修补7天/周(224小时)。预设非劣效性界限为1行。
方法:主要结果是弱视视力(VA)的改善,用重复测量的协方差分析建模。次要结果包括立体敏锐度,双眼VA,和治疗依从性,通过每组中的1样本Wilcoxon检验和比较组的2样本Wilcoxon检验进行分析。安全性结果包括研究相关不良事件(AE)的频率和严重程度。
结果:发现CureSight组的VA改善不劣于修补组的改善(最小分辨率角度的0.28±0.13对数[logMAR][P<0.0001]和0.23±0.14logMAR[P<0.0001],分别为差异的90%置信区间[CI],-0.008至0.076)。在双眼治疗组中观察到0.40log弧秒(P<0.0001)的立体视力改善和改善的双眼VA(0.13logMAR;P<0.0001),修补组在立体视敏度(0.40对数弧秒;P<0.0001)和双眼VA(0.09logMAR;P<0.0001)方面有类似的改善,两组的立体视力改善无显著差异(差异,0;95%CI,-0.27至-0.27;P=0.76)或双眼VA(差异,0.041;95%CI,-0.002至0.085;P=0.07)。双眼治疗组的依从性明显高于修补组(91%vs.83%;95%CI,-4.0%至21%;P=0.011)。没有发现严重的AE。
结论:4至<9岁弱视儿童的双眼治疗耐受性良好,且不劣于补片。高依从性可能为弱视提供替代治疗选择。
背景:专利或商业公开可以在参考文献之后找到。
Comparing visual outcomes after use of a novel binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd) with patching.
Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial.
One hundred three children 4 to < 9 years with anisometropic, small-angle strabismic or mixed-mechanism amblyopia were randomized 1:1 to either CureSight treatment or patching.
The CureSight treatment uses combined anaglyph glasses and an eye tracker to induce real-time blur around the fellow eye fovea in dichoptic streamed video content. Participants used the device for 90 minutes/day, 5 days/week for 16 weeks (120 hours). The patching group received 2 hours of patching 7 days/week (224 hours). The prespecified noninferiority margin was 1 line.
The primary outcome was the improvement in the amblyopic eye visual acuity (VA), modeled with a repeated measures analysis of covariance. Secondary outcomes included stereoacuity, binocular VA, and treatment adherence rates, analyzed by a 1-sample Wilcoxon test within each group and a 2-sample Wilcoxon test comparing groups. Safety outcomes included the frequency and severity of study-related adverse events (AEs).
CureSight group VA improvement was found to be noninferior to patching group improvement (0.28 ± 0.13 logarithm of the minimum angle of resolution [logMAR] [P < 0.0001] and 0.23 ± 0.14 logMAR [P < 0.0001], respectively; 90% confidence interval [CI] of difference, -0.008 to 0.076). Stereoacuity improvement of 0.40 log arcseconds (P < 0.0001) and improved binocular VA (0.13 logMAR; P < 0.0001) were observed in the binocular treatment group, with similar improvements in the patching group in stereoacuity (0.40 log arcseconds; P < 0.0001) and binocular VA (0.09 logMAR; P < 0.0001), with no significant difference between improvements in the 2 groups in either stereoacuity (difference, 0; 95% CI, -0.27 to -0.27; P = 0.76) or binocular VA (difference, 0.041; 95% CI, -0.002 to 0.085; P = 0.07). The binocular treatment group had a significantly higher adherence than the patching group (91% vs. 83%; 95% CI, -4.0% to 21%; P = 0.011). No serious AEs were found.
Binocular treatment was well tolerated and noninferior to patching in amblyopic children 4 to < 9 years of age. High adherence may provide an alternative treatment option for amblyopia.
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