UNASSIGNED:与双焦点(DF)和单视(SV)设计相比,采用非同轴环焦点设计(用于增强功效[EE]和增强视力[EV])的2种原型近视控制软性隐形眼镜的疗效和视力。
未经评估:多中心,6个月,随机化,控制,双盲临床试验.
UNASISIGNED:一百九十九名7至12岁的近视(-0.75屈光度[D]至-4.50D)儿童。
未经评估:参与者被随机分层为近视对照(EE,EV,或DF)或SV臂在3个国家的9个临床地点。在基线和26周时测量睫状肌麻痹后轴向长度(AL)和球面等效自屈光(SECAR)。基线时无睫状肌麻痹时也测量轴向长度,1、4、13和26周。使用线性混合模型按意向治疗人群分析进展。监测视敏度(VA)和视觉质量。
未经批准:轴向伸长率,SECAR的变化。
未经评估:共有185名受试者完成了研究(EE的n=44、49、45和47,EV,DF,SV,分别)。没有严重/显著的眼部不良事件。26周后,EE,EV,和DF的轴向伸长率均显著低于SV(未调整平均值[标准偏差]:EE,0.079[0.125];EV,0.119[0.101];DF,0.135[0.117];SV;0.189[0.121]mm)。与SV相比,估计的最小二乘均值(LSM)差异(调整后的95%置信区间)为-0.105(-0.149,-0.062),-0.063(-0.106,-0.020),EE为-0.056(-0.100,-0.013)mm,EV,DF,分别。与SV相比,单独增强疗效的SECAR进展在统计学上显着较少(EE:-0.12[0.27]Dvs.SV:-0.35[0.33]D;LSM差:0.22D[0.09,0.35])。增强功效还具有统计学上显著小于DF(-0.049mm[-0.093,-0.004])的轴向伸长率。EV和DF的AL和SECAR变化无统计学差异。所有3个近视对照镜片的平均VA接近最小分辨率角(logMAR)的0.00对数,估计95%置信上限<0.10logMAR。增强疗效和DF产生了类似的光环报告,但超过了EV和SV。
UNASSIGNED:原型隐形眼镜符合设计意图;EE在减缓轴向伸长方面比DF更有效,具有可比的视觉性能,而EV的功效与DF相当,视力表现与SV相似。
UNASSIGNED: To evaluate efficacy and vision with 2 prototype myopia control soft contact lenses with noncoaxial ring-focus designs (for enhancing efficacy [EE] and enhancing vision [EV]) compared with dual-focus (DF) and single-vision (SV) designs.
UNASSIGNED: Multicenter, 6-month, randomized, controlled, double-masked clinical trial.
UNASSIGNED: One hundred ninety-nine myopic (-0.75 diopters [D] to -4.50 D) children aged 7 to 12 years.
UNASSIGNED: Participants were randomized with stratification into myopia control (EE, EV, or DF) or SV arms at 9 clinical sites in 3 countries. Postcycloplegia axial length (AL) and spherical equivalent autorefraction (SECAR) were measured at baseline and 26 weeks. Axial length was also measured without cycloplegia at baseline, 1, 4, 13, and 26 weeks. Progression was analyzed using linear mixed models by intention-to-treat population. Visual acuity (VA) and vision quality were monitored.
UNASSIGNED: Axial elongation, change in SECAR.
UNASSIGNED: A total of 185 subjects completed the study (n = 44, 49, 45, and 47 for EE, EV, DF, and SV, respectively). There were no serious/significant ocular adverse events. After 26 weeks, EE, EV, and DF all had statistically significantly less axial elongation than SV (unadjusted mean [standard deviation]: EE, 0.079 [0.125]; EV, 0.119 [0.101]; DF, 0.135 [0.117]; SV; 0.189 [0.121] mm). The estimated least-square mean (LSM) differences (adjusted 95% confidence interval) compared with SV were -0.105 (-0.149, -0.062), -0.063 (-0.106, -0.020), and -0.056 (-0.100, -0.013) mm for EE, EV, and DF, respectively. Enhancing efficacy alone had statistically significantly less progression of SECAR than SV (EE: -0.12 [0.27] D vs. SV: -0.35 [0.33] D; LSM difference: 0.22 D [0.09, 0.35]). Enhancing efficacy also had statistically significantly less axial elongation than DF (-0.049 mm [-0.093, -0.004]). Changes in AL and SECAR of EV and DF were not statistically different. All 3 myopia control lenses had mean VA close to 0.00 logarithm of the minimum angle of resolution (logMAR) with estimated 95% upper confidence limits <0.10 logMAR. Enhancing efficacy and DF produced similar reports of halos but more than EV and SV.
UNASSIGNED: The prototype contact lenses met the design intent; EE was more efficacious in slowing axial elongation than DF with comparable vision performance, whereas EV produced comparable efficacy to DF with similar vision performance to SV.