Center of Ophthalmology, University of Cologne, 50924 Cologne, Germany.
Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):201-9. doi: 10.1007/s00417-011-1792-8. Epub 2011 Sep 8.
The efficacy of ranibizumab in preserving visual acuity in exudative age-related macular degeneration (AMD) has been widely demonstrated. However, statistically significant improvements in outcome measures such as best-corrected visual acuity (BCVA) may not necessarily be clinically relevant. Clinical relevance can be assumed when the treatment success is perceivable for the patient. We therefore investigated the relation between subjective perception of the treatment success and the objective outcome after intravitreal ranibizumab treatment.
In this prospective interventional case series, patients received three monthly ranibizumab injections for exudative AMD. To assess the subjective study outcome (SSO) 4 weeks after the third injection, patients had to grade the overall trend of visual quality in the treated eye since baseline. Objective changes of functional (BCVA measured with ETDRS reading charts; reading visual acuity (RVA) and reading speed measured with Radner reading charts) and morphological parameters (central retinal thickness measured with OCT) were evaluated. Agreement between SSO and objective parameters was assessed with nonparametric statistical tests.
Seventy-four eyes of 74 patients were analyzed. Mean BCVA increased from 55 (SD ±13) ETDRS letters by +3.16 letters (SD ±11.99, p = 0.03). Mean RVA (measured as logRAD score) increased by -0.067 (SD ±0.294, p = 0.052). Fifty patients (68%) perceived a subjective improvement, 16 (21%) no change, and eight (11%) a worsening in the study eye (SSO). SSO was independent of whether treating the better- or worse-seeing eye (p = 0.83). SSO was significantly correlated with BCVA, RVA, and reading speed (as assessed using the critical print size (CPS)) changes (p = 0.002, p < 0.001, and p = 0.002), but showed no correlation to central retinal thickness changes (p = 0.783). Patients gaining ≥ +5 ETDRS letters had a significantly better SSO (p = 0.001). The rate of subjective improvement increased distinctly to >80% among patients gaining ≥ +7 letters.
In this study, 2/3 of patients reported a subjective improvement from ranibizumab injections. Patients' perception was significantly correlated with objective changes in BCVA and reading visual acuity. Our data indicate that the mean threshold for perceived improvement is a +5 to +7 letter gain, which might accordingly be considered clinically meaningful and relevant. Patients' perception was independent of whether the better- or worse-seeing eye was treated.
雷珠单抗在保存渗出性年龄相关性黄斑变性（AMD）患者视力方面的疗效已得到广泛证实。然而，最佳矫正视力（BCVA）等结局指标的统计学显著改善不一定具有临床意义。当治疗效果对患者来说是可感知的时候，就可以认为是有临床意义的。因此，我们研究了患者对治疗成功的主观感知与玻璃体内雷珠单抗治疗后的客观结果之间的关系。
在这项前瞻性的干预性病例系列研究中，患者接受了三次每月一次的雷珠单抗注射治疗渗出性 AMD。为了评估第三次注射后 4 周的主观研究结果（SSO），患者必须对自基线以来治疗眼的整体视觉质量趋势进行评分。使用 ETDRS 阅读图表评估功能参数（BCVA 测量值；使用 Radner 阅读图表评估阅读视力（RVA）和阅读速度）和形态参数（OCT 测量的中央视网膜厚度）的变化。使用非参数统计检验评估 SSO 与客观参数之间的一致性。
分析了 74 名患者的 74 只眼。BCVA 均值从 55（SD±13）个 ETDRS 字母增加到+3.16 个字母（SD±11.99，p=0.03）。RVA（以 logRAD 评分表示）均值下降了-0.067（SD±0.294，p=0.052）。50 名患者（68%）主观上认为治疗有改善，16 名（21%）没有变化，8 名（11%）认为治疗眼（SSO）恶化。SSO 与治疗优势眼或劣势眼无关（p=0.83）。SSO 与 BCVA、RVA 和阅读速度（以临界印刷大小（CPS）评估）的变化显著相关（p=0.002，p<0.001 和 p=0.002），但与中央视网膜厚度的变化无相关性（p=0.783）。获得≥+5 ETDRS 字母的患者 SSO 明显更好（p=0.001）。获得≥+7 个字母的患者中，主观改善的比例明显增加到>80%。
在这项研究中，2/3 的患者报告了雷珠单抗注射后的主观改善。患者的感知与 BCVA 和阅读视力的客观变化显著相关。我们的数据表明，感知改善的平均阈值为+5 至+7 个字母的提高，这可能被认为具有临床意义和相关性。患者的感知与治疗优势眼或劣势眼无关。
