Simons K, Gotzler K C, Vitale S
Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9009, USA.
Ophthalmology. 1997 Dec;104(12):2156-60. doi: 10.1016/s0161-6420(97)30047-5.
The purpose of the study is to compare the visual outcome of occlusion versus penalization treatment of strabismic amblyopia, with particular attention to binocularity outcome.
The study design was a retrospective study.
Patients with strabismic amblyopia, 75 receiving penalization alone, 87 with a history of occlusion treatment who were later treated by penalization, and 30 treated by means of part-time occlusion (2 to 6 hours/day) participated in this study.
Logarithm of the minimum angle of resolution (logMAR) visual acuity and binocularity index were measured.
No statistically significant difference was found between outcomes for the penalization groups with and without a history of occlusion, either by univariate analysis or by multivariate analysis controlling for initial-visit age, acuity, and binocularity status. One marginally significant outcome difference was found between the pure penalization and part-time occlusion groups by univariate analysis, but no significant difference was found in the multivariate analyses controlling for the same three variables at the initial visit. All visual outcome differences between the pure penalization and part-time occlusion groups were less than 1 logMAR line visual acuity or less than a half-unit on the binocularity index.
The study provided no evidence of a difference in visual function outcome between penalization and occlusion, in terms of either statistical or clinical significance, although limitations of the patient samples used preclude these data from showing conclusively that there was no such difference. The lack of any other study adequately comparing these two treatment methods, in combination with the current study's demonstration of the difficulty of making adequate retrospective-based comparison despite a large patient base (n = 1413), suggests that a large prospective, randomized comparative treatment trial is needed. If atropine penalization, with its high acceptability to patients and parents, is found to produce results comparable with those of occlusion in cases of mild-to-moderate amblyopia, as the current and previous smaller studies suggest, then reconsideration of the standard of care for such amblyopia cases is indicated.
本研究旨在比较斜视性弱视的遮盖疗法与压抑疗法的视觉效果，尤其关注双眼视功能的结果。
本研究为回顾性研究。
斜视性弱视患者，75例仅接受压抑疗法，87例有遮盖治疗史且之后接受压抑疗法，30例接受部分时间遮盖（每天2至6小时）治疗并参与本研究。
测量最小分辨角对数（logMAR）视力和双眼视功能指数。
单因素分析或控制初诊年龄、视力和双眼视功能状态的多因素分析均显示，有遮盖治疗史的压抑疗法组与无遮盖治疗史的压抑疗法组之间的结果无统计学显著差异。单因素分析发现单纯压抑疗法组与部分时间遮盖组之间有一个边缘显著的结果差异，但在控制初诊时相同三个变量的多因素分析中未发现显著差异。单纯压抑疗法组与部分时间遮盖组之间的所有视觉效果差异均小于1个logMAR视力行或双眼视功能指数小于半个单位。
本研究未提供证据表明压抑疗法和遮盖疗法在视觉功能结果上存在统计学或临床意义上的差异，尽管所使用的患者样本存在局限性，使得这些数据无法确凿地表明不存在这种差异。由于缺乏其他充分比较这两种治疗方法的研究，再加上本研究表明尽管患者基数较大（n = 1413），但基于回顾性进行充分比较存在困难，这表明需要进行一项大型前瞻性、随机对照治疗试验。如果如当前及之前较小规模研究所表明的，对于轻至中度弱视病例，阿托品压抑疗法因其对患者和家长具有较高的可接受性，且产生的结果与遮盖疗法相当，那么对于此类弱视病例的治疗标准则需要重新考虑。
