Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2749-57. doi: 10.1167/iovs.10-6631.
To determine whether progressive-addition lenses (PALs) relative to single-vision lenses (SVLs) slow the progression of low myopia in children with high accommodative lag and near esophoria.
One hundred eighteen children 8 to <12 years of age with spherical equivalent refraction (SER) from -0.75 to -2.50 D and near esophoria ≥2 PD were enrolled in this double-masked multicenter randomized trial. A key additional eligibility criterion was high accommodative lag, initially defined as at least 0.50 D (accommodative response less than 2.50 D for a 3.00-D demand) and later restricted further to at least 1.00 D. One hundred four subjects had accommodative lag of at least 1.00 D, and 14 had lag between 0.50 and 0.99 D. The children were randomized to receive either PALs with a +2.00-D addition or standard SVLs. The clinicians performing the outcome testing, as well as the children and their families, were masked to treatment group. Follow-up visits occurred every 6 months for 3 years. At annual visits, refractive error was assessed in each eye by using cycloplegic autorefraction. The main outcome measure was change from baseline to 3 years in SER by cycloplegic autorefraction.
The mean change in SER between baseline and the 3-year primary outcome visit was -0.87 D in the PAL group and -1.15 D in the SVL group, for a difference of 0.28 D (95% confidence interval [CI], 0.01-0.55D).
The PALs used in this study were found to have a statistically but not clinically significant effect of slowing myopia progression in children with high accommodative lag and near esophoria. (ClinicalTrials.gov number, NCT00320593.).
研究调节滞后量较高伴内隐性外斜视的儿童戴渐进多焦点镜片(PALs)对比戴单焦点镜片(SVLs)能否延缓近视进展。
本研究为双盲、多中心、随机临床试验,共纳入 118 名年龄 8 岁至<12 岁、球镜等效屈光度(SER)为-0.75 至-2.50D、近隐斜度≥2 PD 的儿童。入组的一个关键标准是调节滞后量高,最初的定义是至少 0.50D(3.00D 的需求刺激下调节反应小于 2.50D),随后进一步限定为至少 1.00D。104 名患儿的调节滞后量至少为 1.00D,14 名患儿的滞后量在 0.50 至 0.99D 之间。这些患儿被随机分配到接受+2.00D 附加的 PAL 或标准 SVL。进行结果检测的临床医生以及患儿及其家属均对治疗分组设盲。随访时间为 3 年,每 6 个月 1 次。在每年的随访中,使用睫状肌麻痹下自动验光仪对双眼进行屈光不正评估。主要结局是使用睫状肌麻痹下自动验光仪评估 3 年随访时的 SER 与基线的差值。
在 PAL 组和 SVL 组,从基线至 3 年主要结局观察点,SER 的平均变化量分别为-0.87D 和-1.15D,差值为 0.28D(95%置信区间[CI],0.01~0.55D)。
本研究中使用的 PALs 被发现能在调节滞后量较高伴内隐性外斜视的儿童中,在统计学上而非临床上显著延缓近视进展。(临床试验注册号:NCT00320593.)