Holmes Jonathan M, Beck Roy W, Kraker Raymond T, Cole Stephen R, Repka Michael X, Birch Eileen E, Felius Joost, Christiansen Stephen P, Coats David K, Kulp Marjean T
Arch Ophthalmol. 2003 Nov;121(11):1625-32. doi: 10.1001/archopht.121.11.1625.
To assess the psychosocial impact on the child and family of patching and atropine as treatments for moderate amblyopia in children younger than 7 years.
In a randomized, controlled clinical trial, 419 children younger than 7 years with amblyopic eye visual acuity in the range of 20/40 to 20/100 were assigned to receive treatment with either patching or atropine at 47 clinical sites. After 5 weeks of treatment, a parental quality-of-life questionnaire was completed for 364 (87%) of the 419 patients. Main Outcome Measure Overall and subscale scores on the Amblyopia Treatment Index.
High internal validity and reliability were demonstrated for the Amblyopia Treatment Index questionnaire. The overall Amblyopia Treatment Index scores and the 3 subscale scores were consistently higher (worse) in the patching group compared with the atropine-treated group (overall mean, 2.52 vs 2.02, P<.001; adverse effects of treatment: mean, 2.35 vs 2.11, P =.002; difficulty with compliance: mean, 2.46 vs 1.99, P<.001; and social stigma: mean, 3.09 vs 1.84, P<.001, respectively).
Although the Amblyopia Treatment Index questionnaire results indicated that both atropine and patching treatments were well tolerated by the child and family, atropine received more favorable scores overall and on all 3 questionnaire subscales.
评估眼罩遮盖法和阿托品疗法对7岁以下儿童中度弱视患儿及其家庭的心理社会影响。
在一项随机对照临床试验中,419名7岁以下弱视眼视力在20/40至20/100之间的儿童被分配到47个临床地点接受眼罩遮盖法或阿托品疗法。治疗5周后,419名患者中的364名(87%)家长完成了一份生活质量问卷。主要结局指标为弱视治疗指数的总体得分和各子量表得分。
弱视治疗指数问卷显示出较高的内部效度和信度。与阿托品治疗组相比,眼罩遮盖法治疗组的弱视治疗指数总体得分及3个子量表得分均持续较高(更差)(总体平均分:2.52对2.02,P<0.001;治疗不良反应:平均分2.35对2.11,P = 0.002;依从性困难:平均分2.46对1.99,P<0.001;社会污名:平均分3.09对1.84,P<0.001)。
尽管弱视治疗指数问卷结果表明,阿托品疗法和眼罩遮盖法治疗患儿及其家庭的耐受性均良好,但阿托品疗法在总体及所有3个问卷子量表上的得分更高。