Freedman Sharon F, Lynn Michael J, Beck Allen D, Bothun Erick D, Örge Faruk H, Lambert Scott R
Duke Eye Center, Duke University Medical Center, Durham, North Carolina.
Department of Biostatistics and Bioinformatics, Rollins School of Public Health of Emory University, Atlanta, Georgia.
JAMA Ophthalmol. 2015 Aug;133(8):907-14. doi: 10.1001/jamaophthalmol.2015.1329.
Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy, yet their relationship to aphakia vs primary intraocular lens (IOL) implantation remains unsettled.
To identify and characterize cases of glaucoma and glaucoma-related adverse events (glaucoma + glaucoma suspect) among children in the Infant Aphakia Treatment Study by the age of 5 years.
DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized clinical trial of 114 infants with unilateral congenital cataract in referral centers who were between ages 1 and 6 months at surgery. Mean follow-up was 4.8 years. This secondary analysis was conducted from December 23, 2004, to November 13, 2013.
Participants were randomized at cataract surgery to either primary IOL or no IOL implantation (contact lens). Standardized definitions of glaucoma and glaucoma suspect were created for the Infant Aphakia Treatment Study and applied for surveillance and diagnosis.
Development of glaucoma and glaucoma + glaucoma suspect in operated on eyes for children up to age 5 years, plus intraocular pressure, visual acuity, and axial length at age 5 years.
Product limit estimates of the risk for glaucoma and glaucoma + glaucoma suspect at 4.8 years after surgery were 17% (95% CI, 11%-25%) and 31% (95% CI, 24%-41%), respectively. The contact lens and IOL groups were not significantly different for either outcome: glaucoma (hazard ratio [HR], 0.8; 95% CI, 0.3-2.0; P = .62) and glaucoma + glaucoma suspect (HR, 1.3; 95% CI, 0.6-2.5; P = .58). Younger (vs older) age at surgery conferred an increased risk for glaucoma (26% vs 9%, respectively) at 4.8 years after surgery (HR, 3.2; 95% CI, 1.2-8.3), and smaller (vs larger) corneal diameter showed an increased risk for glaucoma + glaucoma suspect (HR, 2.5; 95% CI, 1.3-5.0). Age and corneal diameter were significantly positively correlated. Glaucoma was predominantly open angle (19 of 20 cases, 95%), most eyes received medication (19 of 20, 95%), and 8 of 20 eyes (40%) underwent surgery.
These results suggest that glaucoma-related adverse events are common and increase between ages 1 and 5 years in infants after unilateral cataract removal at 1 to 6 months of age; primary IOL placement does not mitigate their risk but surgery at a younger age increases the risk. Longer follow-up of these children may further characterize risk factors, long-term outcomes, potential differences between eyes having primary IOL vs aphakia, and optimal timing of unilateral congenital cataract removal.
clinicaltrials.gov Identifier: NCT00212134.
青光眼相关不良事件是婴儿期白内障摘除术后主要的视力威胁性并发症，但其与无晶状体状态及一期人工晶状体（IOL）植入的关系仍未明确。
在婴儿无晶状体治疗研究中，确定5岁以下儿童青光眼及青光眼相关不良事件（青光眼+青光眼可疑病例）的情况并进行特征描述。
设计、地点和参与者：一项多中心随机临床试验，纳入114例转诊中心的单侧先天性白内障婴儿，手术时年龄在1至6个月。平均随访4.8年。该二次分析于2004年12月23日至2013年11月13日进行。
参与者在白内障手术时随机分为一期IOL植入组或无IOL植入组（佩戴角膜接触镜）。为婴儿无晶状体治疗研究制定了青光眼和青光眼可疑病例的标准化定义，并应用于监测和诊断。
5岁以下儿童手术眼发生青光眼和青光眼+青光眼可疑病例的情况，以及5岁时的眼压、视力和眼轴长度。
术后4.8年青光眼和青光眼+青光眼可疑病例风险的乘积限估计分别为17%（95%CI，11%-25%）和31%（95%CI,24%-41%）。两种结局在角膜接触镜组和IOL组之间无显著差异：青光眼（风险比[HR]，0.8；95%CI，0.3-2.0；P = 0.62）和青光眼+青光眼可疑病例（HR，1.3；95%CI，0.6-2.5；P = 0.58）。手术时年龄较小（与较大相比）在术后4.8年发生青光眼的风险增加（分别为26%和9%）（HR，3.2；95%CI，1.2-8.3），角膜直径较小（与较大相比）显示青光眼+青光眼可疑病例的风险增加（HR，2.5；95%CI，1.3-5.0）。年龄与角膜直径呈显著正相关。青光眼主要为开角型（20例中的19例，95%），大多数眼接受了药物治疗（20例中的19例，95%），20只眼中有8只（40%）接受了手术。
这些结果表明，青光眼相关不良事件在1至6个月龄单侧白内障摘除术后的婴儿中很常见，且在1至5岁之间增加；一期IOL植入并不能降低其风险，但手术时年龄较小会增加风险。对这些儿童进行更长时间的随访可能会进一步明确危险因素、长期结局、一期IOL植入眼与无晶状体眼之间的潜在差异以及单侧先天性白内障摘除的最佳时机。
clinicaltrials.gov标识符：NCT00212134。
