婴儿期单眼无晶状体的隐形眼镜与人工晶状体矫正比较：4.5岁时HOTV视标视力及5岁时临床结果的随机临床试验
Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years.
作者信息
Lambert Scott R, Lynn Michael J, Hartmann E Eugenie, DuBois Lindreth, Drews-Botsch Carolyn, Freedman Sharon F, Plager David A, Buckley Edward G, Wilson M Edward
出版信息
JAMA Ophthalmol. 2014 Jun;132(6):676-82. doi: 10.1001/jamaophthalmol.2014.531.
IMPORTANCE
The efficacy and safety of primary intraocular lens (IOL) implantation during early infancy is unknown.
OBJECTIVE
To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy.
DESIGN, SETTING, AND PARTICIPANTS: The Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites. A traveling examiner assessed visual acuity at age 4.5 years.
INTERVENTIONS
Cataract surgery with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Treatment was determined through random assignment.
MAIN OUTCOMES AND MEASURES
HOTV optotype visual acuity at 4.5 years of age.
RESULTS
The median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups (both, 0.90 [20/159]; P = .54). About 50% of treated eyes in both groups had visual acuity less than or equal to 20/200. Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery (contact lens, 56%; IOL, 81%; P = .02). The most common adverse events in the IOL group were lens reproliferation into the visual axis, pupillary membranes, and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs 28% of eyes in the IOL group (P = .55). Since the initial cataract surgery, significantly more patients in the IOL group have had at least 1 additional intraocular surgery (contact lens, 21%; IOL, 72%; P < .001).
CONCLUSIONS AND RELEVANCE
There was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic. However, there were significantly more adverse events and additional intraoperative procedures in the IOL group. When operating on an infant younger than 7 months of age with a unilateral cataract, we recommend leaving the eye aphakic and focusing the eye with a contact lens. Primary IOL implantation should be reserved for those infants where, in the opinion of the surgeon, the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00212134
重要性
婴儿早期植入人工晶状体（IOL）的有效性和安全性尚不清楚。
目的
比较婴儿早期单侧白内障手术后，佩戴隐形眼镜与植入人工晶状体进行光学矫正的患者的视力结果。
设计、地点和参与者：婴儿无晶状体治疗研究是一项随访5年的随机临床试验，涉及12个地点的114例单侧先天性白内障婴儿。一名巡回检查人员评估了4.5岁时的视力。
干预措施
白内障手术，伴或不伴一期人工晶状体植入。未接受人工晶状体植入的患者使用隐形眼镜矫正无晶状体眼。治疗通过随机分配确定。
主要结局和测量指标
4.5岁时的HOTV视标视力。
结果
两个治疗组中治疗眼的平均对数最小分辨角视力无显著差异（均为0.90[20/159]；P = 0.54）。两组中约50%的治疗眼视力小于或等于20/200。人工晶状体组中白内障手术后至少发生1次不良事件的患者显著更多（隐形眼镜组为56%，人工晶状体组为81%；P = 0.02）。人工晶状体组最常见的不良事件是晶状体再生进入视轴、瞳孔膜和瞳孔异位。隐形眼镜组35%的治疗眼发生青光眼/疑似青光眼，人工晶状体组为28%（P = 0.55）。自初次白内障手术以来，人工晶状体组中至少进行过1次额外眼内手术的患者显著更多（隐形眼镜组为21%，人工晶状体组为72%；P < 0.001）。
结论和相关性
接受一期人工晶状体植入的儿童与无晶状体眼儿童的手术眼平均视力无显著差异。然而，人工晶状体组的不良事件和额外的术中操作显著更多。对于7个月以下单侧白内障婴儿进行手术时，我们建议保留眼的无晶状体状态，并用隐形眼镜聚焦该眼。一期人工晶状体植入应保留给外科医生认为佩戴隐形眼镜的成本和操作负担过重，以至于会导致无晶状体眼长时间未矫正的婴儿。
试验注册
clinicaltrials.gov标识符：NCT00212134
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