Division of Ophthalmology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
PLoS One. 2024 Aug 20;19(8):e0304566. doi: 10.1371/journal.pone.0304566. eCollection 2024.
Full-thickness macular holes (FTMH) are defects in the fovea involving all neural retinal layers. They reduce patients' visual acuity (VA) and impact their quality of life. FTMHs are repaired with pars plana vitrectomy (PPV) with intraocular gas tamponade and post-operative face-down positioning (FDP). There is no consensus regarding the ideal positioning requirements following FTMH repair and there lacks clear guidelines on the topic. While analysis of global practice patterns indicates that between 5-7 days is the most common duration suggested by surgeons, there is significant heterogeneity in surgeon preferences. There is, however, biological plausibility to support minimal or even no FDP following surgery and given the disabling nature of FDP for patients, there is a need to better assess key patient outcomes with different FDP durations. As such, this prospective randomized controlled pilot trial will compare 3-days of FDP to 7-days of FDP following PPV for FTMH.
This single-centered, parallel-group randomized controlled pilot trial will randomize patients 1:1 following PPV to 3 days or 7 days of FDP. This investigation has been approved by the local ethics board (HiREB # 16100) and has been registered on clinicaltrials.gov (NCT06000111). The primary objective will be focused on assessing the feasibility of a larger trial; this will be determined through an assessment of the recruitment rate, retention rate, completion rate and recruitment time. The secondary outcomes involve assessment of the following patient-important outcomes a) macular hole closure rate, b) best-recorded VA, c) a general quality of life measure and vision-specific quality of life measure, d) patient compliance and e) complication rates. Outcomes will be evaluated at 3 months following surgery.
The results of this pilot study will determine the feasibility of a larger-scale trial that will answer a patient important question with clinical equipoise.
全层黄斑裂孔（FTMH）是累及所有神经视网膜层的黄斑中心凹缺损。它们会降低患者的视力（VA）并影响他们的生活质量。FTMH 通过经睫状体平坦部玻璃体切除术（PPV）联合眼内气体填充和术后面朝下体位（FDP）进行修复。目前，对于 FTMH 修复后理想的体位要求尚未达成共识，也缺乏关于该主题的明确指南。虽然对全球实践模式的分析表明，5-7 天是外科医生最常建议的时间，但外科医生的偏好存在显著差异。尽管手术后 FDP 对患者具有致残性，但从生物学角度来看，支持最小化甚至无需 FDP 是合理的，因此，需要更好地评估不同 FDP 持续时间对关键患者结局的影响。因此，这项前瞻性随机对照试验将比较 FTMH 经 PPV 手术后 3 天和 7 天 FDP 的疗效。
这项单中心、平行组随机对照试验将在 PPV 后对患者进行 1:1 随机分组，分为 3 天或 7 天 FDP 组。该研究已获得当地伦理委员会（HiREB # 16100）的批准，并已在 clinicaltrials.gov 上注册（NCT06000111）。主要目的将集中评估更大规模试验的可行性；这将通过评估招募率、保留率、完成率和招募时间来确定。次要结局包括评估以下患者重要结局：a）黄斑裂孔闭合率、b）最佳记录视力、c）一般生活质量和视力特定生活质量测量、d）患者依从性和 e）并发症发生率。术后 3 个月评估结局。
这项初步研究的结果将确定更大规模试验的可行性，该试验将在存在临床争议的情况下回答一个对患者重要的问题。
