Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA.
Ophthalmology. 2012 Oct;119(10):2014-20. doi: 10.1016/j.ophtha.2012.03.051. Epub 2012 Jun 15.
To evaluate patient-reported outcome measures with the use of ready-made spectacles (RMS) and custom spectacles (CS) in an adult population in India with uncorrected refractive error (URE).
Prospective, double-masked, randomized trial with 1-month follow-up.
A total of 363 adults aged 18 to 45 years with ≥1 diopter (D) of URE (RMS, n = 183; CS, n = 180).
All participants received complete refraction and were randomized to receive CS (full sphero-cylindrical correction) or RMS based on the spherical equivalent for the eye with lower refractive error but limited to the powers in the RMS inventory.
Visual function and quality of life (VFQoL) instrument and participant satisfaction.
Rasch scores for VFQoL increased from 1.14 to 4.37 logits in the RMS group and from 1.11 to 4.72 logits in the CS group: respective mean changes of 3.23 (95% confidence interval [CI], 2.90-3.56) vs. 3.61 (95% CI, 3.34-3.88), respectively. Mean patient satisfaction also increased by 1.83 points (95% CI, 1.60-2.06) on a 5-point Likert scale in the RMS group and by 2.04 points (95% CI, 1.83-2.24) in the CS group. In bivariate analyses, CS was not associated with increased VFQoL or patient satisfaction compared with the RMS group. In the full multivariable linear regression, the CS group had greater improvement when compared with those receiving RMS (+0.45 logits; 95% CI, 0.02-0.88), and subjects with astigmatism >2.00 D had significantly less improvement (-0.99 logits; 95% CI, -1.68 to -0.30) after controlling for demographic and vision-related characteristics. In multivariable analysis, increased change in patient satisfaction was related to demographic and optical characteristics, but not spectacle group.
Ready-made spectacles produce large but slightly smaller improvements in VFQoL and similar satisfaction with vision at 1-month follow-up when compared with CS. Ready-made spectacles are suitable for the majority of individuals with URE in our study population, although those with high degrees of astigmatism may benefit from a trial of CS. This study provides further evidence for the use of RMS in settings where CS are unavailable or unaffordable, or refractive services are inaccessible to those in need.
评估在印度未经矫正屈光不正（URE）的成年人群中，使用现成眼镜（RMS）和定制眼镜（CS）的患者报告结局测量。
具有 1 个月随访的前瞻性、双盲、随机试验。
共有 363 名年龄在 18 至 45 岁之间、URE 为 ≥1 屈光度（D）的成年人（RMS 组，n=183；CS 组，n=180）。
所有参与者均接受全面验光，并根据低屈光不正眼的等效球镜度数随机分为 CS（全球镜-圆柱镜矫正）或 RMS 组，但仅限于 RMS 库存中的功率。
视力功能和生活质量（VFQoL）量表和患者满意度。
RMS 组 VFQoL 的 Rasch 评分从 1.14 提高到 4.37 对数单位，CS 组从 1.11 提高到 4.72 对数单位：分别为 3.23（95%置信区间[CI]，2.90-3.56）和 3.61（95%CI，3.34-3.88）。RMS 组的患者满意度平均增加了 1.83 分（95%CI，1.60-2.06），CS 组增加了 2.04 分（95%CI，1.83-2.24）。在二元分析中，与 RMS 组相比，CS 组并不能提高 VFQoL 或患者满意度。在全多变量线性回归中，与接受 RMS 治疗的患者相比，CS 组的改善程度更大（+0.45 对数单位；95%CI，0.02-0.88），而散光大于 2.00 D 的患者的改善程度明显较低（-0.99 对数单位；95%CI，-1.68 至-0.30），控制了人口统计学和与视力相关的特征。在多变量分析中，患者满意度的变化与人口统计学和光学特征有关，但与眼镜组无关。
与 CS 相比，RMS 在 1 个月随访时可使 VFQoL 有较大但略小的改善，并对视力有相似的满意度。在我们的研究人群中，RMS 适合大多数 URE 患者，尽管那些有高度散光的患者可能受益于 CS 的试用。本研究进一步证明了在 CS 不可用或负担不起的情况下，或者在需要的人无法获得屈光服务的情况下，RMS 的使用。
