视网膜外膜手术中内限制膜自发剥离：来自剥离临床试验的经验教训。

IF 5.7 Q1 OPHTHALMOLOGY

Ophthalmology. Retina Pub Date : 2025-10-01 DOI:10.1016/j.oret.2025.04.015

Yannick Eude MD , Alexandra Poinas PhD , Christelle Volteau , Olivier Lebreton MD , Alexandre Bonissent MD , Paul Fossum MD , Catherine Creuzot-Garcher MD, PhD , Yannick Le Mer MD , Julien Perol MD , June Fortin MSc , Alexandra Jobert PhD , Fanny Billaud OD , Catherine Ivan RN , Michel Weber MD, PhD , Jean-Baptiste Ducloyer MD, PhD

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When the ILM spontaneously peeled off over an area of at least 2 optic disc diameters around the fovea, patients were not randomized and were included in the spontaneous ILM peeling group (SPG). Otherwise, patients were randomized intraoperatively to either the no ILM peeling group (NPG) or the active ILM peeling group (APG).</div></div><div><h3>Main Outcome Measures</h3><div>Microperimetry, best-corrected visual acuity (BCVA) measurements, and OCT findings were assessed at month 1 (M1), M6, and M12. The primary outcome was the difference in microscotoma number between baseline and M6.</div></div><div><h3>Results</h3><div>Of 213 patients, 101 experienced spontaneous ILM peeling and 100 were randomized (APG, n = 51 and NPG, n = 49). In the SPG, 99 patients were included in the baseline characteristics analysis and 75 patients were included in the follow-up characteristics analysis. Baseline characteristics were similar between all groups. 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引用次数: 0

摘要

目的：本研究的目的是确定特发性视网膜前膜（ERM）去除后自发性内限制膜（ILM）剥落（SP）的预测因素，并比较有和没有剥落的患者的结果。设计：剥落研究是一项全国性随机临床试验。参与者：从五个眼科招募有症状的特发性ERM患者。干预措施：玻璃体切除术和ERM夹层。当ILM自发剥离超过中央凹周围至少两个视盘直径的区域时，患者不被随机分组，并被纳入自发ILM剥离组（SPG）。否则，患者在术中被随机分为无ILM剥离组（NPG）或活跃ILM剥离组（APG）。主要观察指标：在第1个月（M1）、M6、M12时评估显微视力、最佳矫正视力（BCVA）测量和光学相干断层扫描结果。主要结果是基线和M6之间显微瘤数量的差异。结果：213例患者中，101例经历SP， 100例随机（APG, n=51， NPG, n=49）。在SPG中，99例患者被纳入基线特征分析，75例患者被纳入随访特征分析。各组的基线特征相似。实验组与实验组之间微点瘤数的差异无统计学意义（NPG组为-4.8±9.9，APG组为-2.2±7.3，SPG组为-2.7±6.9）。M1时，APG组微点瘤数（+1.6±8.9）明显高于SPG组（-1.6±6.2）。结论：实验组与M6组微点瘤数差异无统计学意义。自发ILM剥离是常见的，并与较好的临床结果相关。未发现预测因素。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Spontaneous Peeling of the Internal Limiting Membrane during Epiretinal Membrane Surgery

Purpose

The aim of this study was to identify predictive factors for spontaneous internal limiting membrane (ILM) peeling after idiopathic unilateral epiretinal membrane (ERM) removal and to compare outcomes between patients with and without spontaneous ILM peeling.

Design

The PEELING study was a national randomized clinical trial.

Participants

Patients with symptomatic idiopathic ERM were recruited from 5 ophthalmology departments.

Interventions

Vitrectomy and ERM dissection were performed. When the ILM spontaneously peeled off over an area of at least 2 optic disc diameters around the fovea, patients were not randomized and were included in the spontaneous ILM peeling group (SPG). Otherwise, patients were randomized intraoperatively to either the no ILM peeling group (NPG) or the active ILM peeling group (APG).

Main Outcome Measures

Microperimetry, best-corrected visual acuity (BCVA) measurements, and OCT findings were assessed at month 1 (M1), M6, and M12. The primary outcome was the difference in microscotoma number between baseline and M6.

Results

Of 213 patients, 101 experienced spontaneous ILM peeling and 100 were randomized (APG, n = 51 and NPG, n = 49). In the SPG, 99 patients were included in the baseline characteristics analysis and 75 patients were included in the follow-up characteristics analysis. Baseline characteristics were similar between all groups. The difference in microscotoma number between baseline and M6 was not statistically significant between groups (−4.8 ± 9.9 in NPG, −2.2 ± 7.3 in APG, and −2.7 ± 6.9 in SPG). At M1, the difference in microscotoma number was significantly higher in the APG (+1.6 ± 8.9) than in the SPG (−1.6 ± 6.2, P < 0.001) and NPG (−2.1 ± 10.2, P = 0.006). The BCVA was significantly better in the SPG than in the APG at M1 (P < 0.01) and M6 (P = 0.03) and in the NPG at M6 (P < 0.01) and M12 (P = 0.01). The anatomical ERM recurrence rate was lower in the SPG (4%, n = 3) than in the NPG (19.6%, n = 9 and P = 0.0096) but similar between the SPG and APG (0%). Two patients in the NPG underwent revision surgery.

Conclusions

The difference in microscotoma number between baseline and M6 was not statistically significant between groups. Spontaneous ILM peeling was common and associated with better clinical outcomes. No predictive factors were identified.