de Lima Neto César Rodrigues, de Cabral Vasconcellos José Paulo, Silva Samuel Goulart Nacacio E, Costa Vital Paulino
Department of Ophthalmology, University of Campinas, 251 Vital Brazil St, Campinas, São Paulo, 13083-888, Brazil.
Trials. 2025 Jun 4;26(1):192. doi: 10.1186/s13063-025-08907-6.
Traditional continuous diode laser transscleral cyclophotocoagulation (TCW-TSCPC) has been used for decades to reduce intraocular pressure (IOP) by decreasing aqueous humor (AH) production in patients with glaucoma. Micropulse cyclophotocoagulation (MP-TSCPC) and slow coagulation (SC-TSCPC) are the newest transscleral cyclophotocoagulation (TSCPC) techniques that result in lower inflammation and complication rates compared to the traditional technique. Most publications on TSCPC are case series with a retrospective design with different treatment protocols. The objective of this manuscript is to describe the protocol of a randomized clinical trial (RCT) designed to compare the efficacy and safety of MP-TSCPC and SC-TSCPC in patients with refractory glaucoma followed for 12 months.
This is a parallel, double-arm single-center, double-masked, RCT that will include eyes with refractory glaucoma. Patients with corrected visual acuity (BCVA) ≤ 20/60, IOP > 21 mmHg, and age ≥ 18 years will be randomized to cyclophotocoagulation using the SC-TSCPC or MP-TSCPC techniques. Follow-up visits will be 1 day, 7 days, 30 days, 3, 6, and 12 months after the procedure. Complete success will be defined as an IOP between 6 and 20 mmHg and a minimum of 30% IOP reduction from baseline, without hypotensive medications. Qualified success will be defined by the same parameters but allowing the use of medication. All follow-up examinations will include determination of BCVA, IOP measurement, slit lamp biomicroscopy, fundoscopy, and macular optical coherence tomography (OCT). The number of hypotensive medications and the occurrence of complications will also be documented.
Our study was designed to compare the efficacy and safety of the two most used TSCPC techniques. Most published studies are retrospective and compare the two new techniques only with the traditional technique. This is, to our knowledge, the first RCT comparing MP-TSCPC and SC-TSCPC techniques.
Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-5pckbhj on December 15, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.
传统的连续二极管激光经巩膜睫状体光凝术（TCW - TSCPC）已应用数十年，通过减少青光眼患者房水（AH）生成来降低眼压（IOP）。微脉冲睫状体光凝术（MP - TSCPC）和慢凝术（SC - TSCPC）是最新的经巩膜睫状体光凝术（TSCPC）技术，与传统技术相比，炎症和并发症发生率更低。大多数关于TSCPC的出版物都是回顾性设计的病例系列，采用不同的治疗方案。本手稿的目的是描述一项随机临床试验（RCT）的方案，该试验旨在比较MP - TSCPC和SC - TSCPC在难治性青光眼患者中随访12个月的疗效和安全性。
这是一项平行、双臂单中心、双盲的RCT，将纳入难治性青光眼患者。矫正视力（BCVA）≤20/60、眼压>21 mmHg且年龄≥18岁的患者将被随机分配接受使用SC - TSCPC或MP - TSCPC技术的睫状体光凝术。术后随访时间为术后1天、7天、30天、3个月、6个月和12个月。完全成功定义为眼压在6至20 mmHg之间，且眼压较基线至少降低30%，无需使用降压药物。合格成功定义为相同参数，但允许使用药物。所有随访检查将包括BCVA测定、眼压测量、裂隙灯生物显微镜检查、眼底镜检查和黄斑光学相干断层扫描（OCT）。还将记录降压药物的使用数量和并发症的发生情况。
我们的研究旨在比较两种最常用的TSCPC技术的疗效和安全性。大多数已发表的研究都是回顾性的，仅将这两种新技术与传统技术进行比较。据我们所知，这是第一项比较MP - TSCPC和SC - TSCPC技术的RCT。
于2023年12月15日在巴西临床试验注册平台（ReBEC）RBR - 5pckbhj上进行回顾性注册。该研究已获得巴西坎皮纳斯大学伦理委员会的批准。
