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首页> 外文期刊>JAMA ophthalmology >Atropine vs patching for treatment of moderate amblyopia: Follow-up at 15 years of age of a randomized clinical trial
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Atropine vs patching for treatment of moderate amblyopia: Follow-up at 15 years of age of a randomized clinical trial

机译：阿托品vs贴剂治疗中度弱视：一项15岁以下的随机临床试验随访

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IMPORTANCE: Initial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity. Long-term data on the durability of treatment benefit are needed. OBJECTIVE: To report visual acuity at 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia. DESIGN, SETTING, AND PARTICIPANTS: In a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40 to 20/100) were randomly assigned to patching (minimum of 6 h/d) or atropine sulfate eyedrops, 1% (1 drop daily), for 6 months. Treatment after 6 months was at the discretion of the investigator. Two years after enrollment, an unselected subgroup of 188 children were enrolled into long-term follow-up. INTERVENTION: Initial treatment with patching or atropine with subsequent treatment at investigator discretion. MAIN OUTCOMES AND MEASURES: Visual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes. RESULTS: Mean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR (approximately 20/25); 59.9%of amblyopic eyes had visual acuity of 20/25 or better and 33.3%, 20/20 or better. Mean interocular acuity difference (IOD) at 15 years of age was 0.21 logMAR (2.1 lines); 48.3%had an IOD of 2 or more lines and 71.4%, 1 or more lines. Treatment (other than spectacles) was prescribed for 9 participants (6.1%) aged 10 to 15 years. Mean IOD was similar at examinations at 10 and 15 years of age (2.0 and 2.1 logMAR lines, respectively; P = .39). Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial (mean logMAR, 0.09) compared with those aged 5 to 6 years (mean logMAR, 0.18; P < .001). When we compared subgroups based on original treatment with atropine or patching, no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age (P = .44 and P = .43, respectively). CONCLUSIONS AND RELEVANCE: At 15 years of age, most children treated for moderate amblyopia when younger than 7 years have good visual acuity, although mild residual amblyopia is common. The outcome is similar regardless of initial treatment with atropine or patching. The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000170
机译：重要信息：斑贴和硫酸阿托品滴眼液对另一只眼弱视的初始治疗可改善视力。需要有关治疗益处持久性的长期数据。目的：报告参加中度弱视治疗试验的7岁以下患者在15岁时的视敏度。设计，地点和参与者：在一项多中心临床试验中，将419名弱视儿童（视敏度为20/40至20/100）随机分配为贴片（最低6 h / d）或硫酸阿托品眼药水1％（每天1滴），持续6个月。 6个月后的治疗由研究者决定。入组两年后，未选择的188名儿童亚组入组长期随访。干预：根据研究者的判断，使用贴剂或阿托品进行初始治疗，随后进行治疗。主要结果和测量指标：对弱视和同伴眼睛进行电子早期治疗糖尿病性视网膜病变研究试验，观察15岁时的视敏度。结果：在15岁以下的147名参与者中测得的弱视平均视力为0.14 logMAR（约20/25）; 59.9％的弱视眼的视力为20/25或更高，而33.3％，20/20或更高。 15岁时的平均眼敏度差（IOD）为0.21 logMAR（2.1行）; 48.3％的IOD为2或更多行，71.4％的IOD为1或更多行。已针对10至15岁的9位参与者（6.1％）规定了治疗（眼镜除外）。 10岁和15岁时的平均IOD相似（分别为2.0和2.1 logMAR线; P = 0.39）。参加随机临床试验时年龄小于5岁的那些人（平均logMAR，0.09）在15年检查中获得了更好的视敏度，而5岁至6岁的那些年龄（平均logMAR，0.18; P <.001）。当我们比较基于阿托品或贴剂的原始治疗的亚组时，在15岁时弱视和另一只眼睛的视力没有观察到显着差异（分别为P = 0.44和P = .43）。结论和相关性：尽管轻度残留弱视是常见的，但在15岁时，大多数接受7岁以下中度弱视治疗的儿童具有良好的视力。无论使用阿托品或贴剂进行初始治疗，结果都是相似的。结果表明，弱视治疗的改善一直持续到至少15岁。试验注册：clinicaltrials.gov标识符：NCT00000170

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