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Abstract：
BACKGROUND: Few large randomized controlled trials provide strong evidence to guide surgical repair of primary rhegmatogenous retinal detachment (RRD) repair. The purpose of this factorial, single-blind, randomized controlled trial is to analyze and compare the surgical outcomes, functional visual outcomes, complications, and quality of life associated with RRD repair using (A) pars plana vitrectomy only (PPV) or PPV with scleral buckle (PPV-SB) and (B) sulfur hexafluoride gas (SF6) or perfluoropropane gas (C3F8) tamponade.
METHODS: Eligible patients with moderately complex RRD will be randomized 1:1 to PPV or PPV-SB and 1:1 to SF6 or C3F8 gas tamponade. Approximately 560 patients will be recruited to be able to detect a difference of around 10% in SSAS rate between the groups. Patients will be followed using multimodal imaging and quality of life questionnaires after the surgical repair until 1 year postoperative. The primary outcome will be a single-surgery anatomic success (SSAS), defined as the absence of reoperation for recurrent RRD in the operating room. Secondary outcomes will be pinhole visual acuity (PHVA) at 8-10 weeks and 6 months, final best-corrected visual acuity (BCVA), final retina status (i.e., attached or detached), time to onset of RRD recurrence, severity and number of complications, and questionnaire results.
CONCLUSIONS: This will be the first 2 × 2 factorial RCT examining repair techniques in primary RRD. It will also be the first RCT to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel aspect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina\'s recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence guiding therapeutic decisions and this trial will address (1) whether supplemental SB is justified and (2) whether longer duration gas tamponade with C3F8 is necessary.
BACKGROUND: ClinicalTrials.gov NCT05863312. Registered on 18 May 2023.
METHODS: Eligible patients with moderately complex RRD will be randomized 1:1 to PPV or PPV-SB and 1:1 to SF6 or C3F8 gas tamponade. Approximately 560 patients will be recruited to be able to detect a difference of around 10% in SSAS rate between the groups. Patients will be followed using multimodal imaging and quality of life questionnaires after the surgical repair until 1 year postoperative. The primary outcome will be a single-surgery anatomic success (SSAS), defined as the absence of reoperation for recurrent RRD in the operating room. Secondary outcomes will be pinhole visual acuity (PHVA) at 8-10 weeks and 6 months, final best-corrected visual acuity (BCVA), final retina status (i.e., attached or detached), time to onset of RRD recurrence, severity and number of complications, and questionnaire results.
CONCLUSIONS: This will be the first 2 × 2 factorial RCT examining repair techniques in primary RRD. It will also be the first RCT to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel aspect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina\'s recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence guiding therapeutic decisions and this trial will address (1) whether supplemental SB is justified and (2) whether longer duration gas tamponade with C3F8 is necessary.
BACKGROUND: ClinicalTrials.gov NCT05863312. Registered on 18 May 2023.
摘要：
背景：很少有大型随机对照试验提供强有力的证据来指导原发性孔源性视网膜脱离（RRD）修复的手术修复。这个阶乘的目的，单盲,随机对照试验是分析和比较手术结果，功能性视觉结果，并发症,使用（A）仅进行平坦部玻璃体切除术（PPV）或带巩膜扣的PPV（PPV-SB）和（B）六氟化硫气体（SF6）或全氟丙烷气体（C3F8）填塞，与RRD修复相关的生活质量。
方法：符合条件的中度复杂RRD患者将被随机分为1：1至PPV或PPV-SB，1：1至SF6或C3F8气体填塞。将招募大约560名患者，以便能够检测到两组之间SSAS率的差异约为10％。患者将在手术修复后使用多模式成像和生活质量问卷进行随访，直到术后1年。主要结果将是单次手术解剖成功（SSAS），定义为手术室中复发性RRD没有再手术。次要结果是8-10周和6个月时的针孔视力（PHVA），最终最佳矫正视力（BCVA），最终视网膜状态(即，连接或分离)，RRD复发的发病时间，并发症的严重程度和数量，和问卷调查结果。
结论：这将是首次2×2阶乘RCT检查原发性RRD的修复技术。这也将是第一个比较两种最常见试剂之间的气体填塞的RCT。值得注意的是,它将有足够的动力来检测临床上显著的效应大小。多模态成像的使用也将是这项研究的一个新方面，使我们能够比较在RRD修复后增加SB对视网膜恢复和不同气体填塞的影响。直到现在,RRD的治疗在很大程度上由务实的回顾性队列研究指导.缺乏指导治疗决策的有力证据，该试验将解决（1）补充SB是否合理，以及（2）是否需要使用C3F8进行较长时间的气体填塞。
背景：ClinicalTrials.govNCT05863312。2023年5月18日注册。
方法：符合条件的中度复杂RRD患者将被随机分为1：1至PPV或PPV-SB，1：1至SF6或C3F8气体填塞。将招募大约560名患者，以便能够检测到两组之间SSAS率的差异约为10％。患者将在手术修复后使用多模式成像和生活质量问卷进行随访，直到术后1年。主要结果将是单次手术解剖成功（SSAS），定义为手术室中复发性RRD没有再手术。次要结果是8-10周和6个月时的针孔视力（PHVA），最终最佳矫正视力（BCVA），最终视网膜状态(即，连接或分离)，RRD复发的发病时间，并发症的严重程度和数量，和问卷调查结果。
结论：这将是首次2×2阶乘RCT检查原发性RRD的修复技术。这也将是第一个比较两种最常见试剂之间的气体填塞的RCT。值得注意的是,它将有足够的动力来检测临床上显著的效应大小。多模态成像的使用也将是这项研究的一个新方面，使我们能够比较在RRD修复后增加SB对视网膜恢复和不同气体填塞的影响。直到现在,RRD的治疗在很大程度上由务实的回顾性队列研究指导.缺乏指导治疗决策的有力证据，该试验将解决（1）补充SB是否合理，以及（2）是否需要使用C3F8进行较长时间的气体填塞。
背景：ClinicalTrials.govNCT05863312。2023年5月18日注册。
