State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 7# Jinsui Road, Guangzhou, 510000, China.
Hainan Eye Hospital, Zhongshan Ophthalmic Center, Sun Yat-Sen University Haikou, Hainan, China.
Trials. 2023 Jun 9;24(1):388. doi: 10.1186/s13063-023-07411-z.
Treatment of pediatric cataract remains challenging because of the extremely high incidence of postoperative adverse events (AEs), especially the AEs related to the locations of secondary implanted intraocular lens (IOL). There are two common locations for secondary IOL implantation in pediatric aphakic eyes: ciliary sulcus or in-the-bag implantation. However, there are currently no large, prospective studies comparing complication rates and visual prognosis of in-the-bag versus ciliarysulcus secondary IOL implantation in pediatric patients. Whether or how much secondary in-the-bag IOL implantation benefits the pediatric patients more than sulcus implantation and deserves to be performed routinely by surgeons remains to be elucidated. Here, we describe the protocol of a randomized controlled trial (RCT) designed to evaluate the safety and efficacy of two approaches of IOL implantation in pediatric aphakia.
The study is a multicenter, single-blinded RCT with 10 years of follow-up. Overall, a minimum of 286 eyes (approximately 228 participants assuming 75% have two study eyes) will be recruited. This study will be carried out in four eye clinics across China. Consecutive eligible patients are randomized to undergo either secondary in-the-bag IOL implantation or secondary sulcus IOL implantation. Participants with two eyes eligible will receive the same treatment. The primary outcomes are IOL decentration and the incidence of glaucoma-related AEs. The secondary outcomes include the incidence of other AEs, IOL tilt, visual acuity, and ocular refractive power. Analysis of the primary and secondary outcomes is to be based on the intention-to-treat and per-protocol analysis. Statistical analyses will include the χ test or Fisher's exact test for the primary outcome, mixed model and generalized estimated equation (GEE) model for the secondary outcome, Kaplan-Meier survival curves for the cumulative probability of glaucoma-related AEs over time in each group.
To the best of our knowledge, this study is the first RCT to evaluate the safety and efficacy of secondary IOL implantation in pediatric aphakia. The results will provide high-quality evidence for the clinical guidelines for the treatment of pediatric aphakia.
ClinicalTrials.gov NCT05136950. Registered on 1 November 2021.
由于术后不良事件（AEs）发生率极高，尤其是与继发性植入人工晶状体（IOL）位置相关的 AEs，小儿白内障的治疗仍然具有挑战性。在儿童无晶状体眼中，继发性 IOL 植入有两个常见位置：睫状沟或囊袋内植入。然而，目前尚无大型前瞻性研究比较儿童患者囊袋内与睫状沟继发性 IOL 植入的并发症发生率和视力预后。继发性囊袋内 IOL 植入是否以及在多大程度上比睫状沟植入更有益于儿科患者，是否值得外科医生常规进行，仍有待阐明。在这里，我们描述了一项旨在评估两种儿童无晶状体患者 IOL 植入方法安全性和有效性的随机对照试验（RCT）的方案。
该研究是一项多中心、单盲 RCT，随访时间为 10 年。总体而言，将招募至少 286 只眼（约 228 名参与者，假设 75%的参与者有两只研究眼）。本研究将在中国的四家眼科诊所进行。连续符合条件的患者被随机分为继发性囊袋内 IOL 植入或继发性睫状沟 IOL 植入组。有两只眼符合条件的参与者将接受相同的治疗。主要结局是 IOL 偏心和青光眼相关 AEs 的发生率。次要结局包括其他 AEs、IOL 倾斜、视力和眼屈光力的发生率。主要和次要结局的分析将基于意向治疗和方案分析。统计分析将包括主要结局的 χ 检验或 Fisher 确切检验，次要结局的混合模型和广义估计方程（GEE）模型，以及每组随时间推移青光眼相关 AEs 的累积概率的 Kaplan-Meier 生存曲线。
据我们所知，这是第一项评估儿童无晶状体患者继发性 IOL 植入安全性和有效性的 RCT。研究结果将为儿童无晶状体治疗的临床指南提供高质量的证据。
ClinicalTrials.gov NCT05136950. 于 2021 年 11 月 1 日注册。
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