目的:评估使用丝裂霉素-C(MMC)或Ologen植入物作为联合小梁切开-小梁切除术(CTT)手术的辅助手段相对于非增强CTT手术的有效性和安全性。原发性先天性青光眼(PCG)患者的成功率更高。
方法:在2019年4月至2021年5月期间进行了一项前瞻性三臂随机对照临床试验,针对超过一年的PCG患者的75只眼,对患者进行至少一年的随访。
方法:该研究包括75只眼,仅70只符合纳入标准,并使用计算机程序随机分配到三个研究组中的一个,以生成随机数列表。眼睛接受CTT治疗,没有增加,用MMC增强的CTT,或者用Ologen植入物增强CTT。仅63只眼完成1年的随访,在3个研究组中分布均匀;每组21只眼进行统计学分析。
方法:我们的主要结果指标是报告和比较在一年的随访中,眼内压(IOP)控制并维持在21mmHg以下且未使用抗青光眼药物或额外青光眼手术的患者成功的百分比。次要结果指标包括报告失败,三种手术方式的术中和术后并发症,术后角膜直径,角膜水肿的清除,术后杯/盘(C/D)比值。
结果:CTT组17只眼(81.0%)获得了完全成功,MMC组18眼(85.7%),Ologen组17只眼(81.0%)。CTT组和Ologen组的18只眼(85.7%)均取得了合格的成功(IOP<21,有或没有抗青光眼药物)。MMC组19只眼(90.5%)。在CTT和Ologen组的三只眼睛(14.3%)和MMC组的两只眼睛(9.5%)中观察到失败。基于生存分析,CTT组三个月的累积成功率为95.2%,在6个月时下降到85.7%,并在随访的第9个月和第12个月保持在该水平。关于MMC组,三个月的累积成功概率为95.2%,六个月下降到90.5%,并在随访的第9个月和第12个月保持在该水平。在奥洛根集团,三个月的累积成功概率为85.7%,并在第六天保持在同一水平,9th,12个月的随访,使用对数检验,p值=0.862。
结论:对于PCG患者,CTT是一种安全有效的主要手术干预措施,不需要进行增强,同时保留增强手术用于复发病例。
OBJECTIVE: To evaluate the efficacy and safety of using Mitomycin-C (MMC) or
Ologen implant as an adjunct to combined trabeculotomy-trabeculectomy (CTT) surgery relative to non-augmented CTT surgery in achieving higher success rates in patients with primary congenital glaucoma (PCG).
METHODS: A prospective triple-armed randomized controlled clinical trial was conducted in the period between April 2019 and May 2021, targeting 75 eyes of patients with PCG over one year, with patients being followed up for at least one whole year.
METHODS: The study included 75 eyes; only 70 fulfilled the inclusion criteria and were randomly assigned to one of the three study groups using a computer program to generate random number list. Eyes were treated by either CTT without augmentation, CTT augmented with MMC, or CTT augmented with
Ologen implant. Only 63 eyes completed one year of follow-up and were evenly distributed among the three study groups; with 21 eyes in each group were statistically analyzed.
METHODS: Our primary outcome measure is to report and compare the percentage of patients who demonstrated complete success with intraocular pressure (IOP) controlled and maintained below 21 mmHg without the use of antiglaucoma medications or additional glaucoma surgery over a one-year follow-up. Secondary outcome measures include reporting failure, intra- and postoperative complications of the three surgical modalities, postoperative corneal diameter, clearance of corneal edema, and postoperative cup/disk (C/D) ratio.
RESULTS: Complete success was achieved in 17 eyes (81.0%) in CTT group, 18 eyes (85.7%) in MMC group, and 17 eyes (81.0%) in
Ologen group. Qualified success (IOP < 21 with or without antiglaucoma medications) was achieved in 18 eyes (85.7%) in both the CTT and the Ologen groups, with 19 eyes (90.5%) in the MMC group. Failure was observed in three eyes (14.3%) in both CTT and
Ologen groups and two eyes (9.5%) in the MMC group. Based on survival analysis, CTT group had a cumulative success probability of 95.2% at three months, which dropped to 85.7% at six months and remained at that level for the 9th and 12th months of follow-up. With respect to the MMC group, the cumulative success probability at three months was 95.2%, dropped to 90.5% at six months, and remained at that level for the 9th and 12th months of follow-up. While in the
Ologen group, the cumulative success probability at three months was 85.7% and remained at the same level during the 6th, 9th, and 12th months of follow-up, with p value = 0.862 using the logrank test.
CONCLUSIONS: CTT is a safe and effective primary surgical intervention in patients with PCG without the need for augmentation while preserving the augmented procedure\'s use for recurrent cases.