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Pros and cons of internal limiting membrane peeling during epiretinal membrane surgery: a randomised clinical trial with microperimetry (PEELING)
British Journal of Ophthalmology ( IF 3.7 ) Pub Date : 2025-01-01 , DOI: 10.1136/bjo-2023-324990
Jean-Baptiste Ducloyer 1, 2 , Yannick Eude 3 , Christelle Volteau 4 , Olivier Lebreton 3 , Alexandre Bonissent 3 , Paul Fossum 3 , Ramin Tadayoni 5 , Catherine P Creuzot-Garcher 6 , Yannick Le Mer 7 , Julien Perol 8 , June Fortin 4 , Alexandra Jobert 4 , Fanny Billaud 2, 3 , Catherine Ivan 2, 3 , Alexandra Poinas 2 , Michel Weber 2, 3 ,
Affiliation  

Background After idiopathic epiretinal membrane (iERM) removal, it is unclear whether the internal limiting membrane (ILM) should be removed. The objective was to assess if active ILM peeling after iERM removal could induce microscotomas. Methods The PEELING study is a national randomised clinical trial. When no spontaneous ILM peeling occurred, patients were randomised either to the ILM peeling or no ILM peeling group. Groups were compared at the month 1 (M1), M6 and M12 visits in terms of microperimetry, best-corrected visual acuity (BCVA) and optical coherence tomography findings. The primary outcome was the difference in microscotoma number between baseline and M6. Results 213 patients were included, 101 experienced spontaneous ILM peeling and 100 were randomised to the ILM peeling (n=51) or no ILM peeling group (n=49). The difference in microscotoma number between both groups was significant at M1 (3.9 more microscotomas in ILM peeling group, (0.8;7.0) p=0.0155) but not at M6 (2.1 more microscotomas in ILM peeling group (−0.5;4.7) p=0.1155). Only in the no ILM peeling group, the number of microscotomas significantly decreased and the mean retinal sensitivity significantly improved. The ERM recurred in nine patients in the no ILM peeling group (19.6%) versus zero in the ILM peeling group (p=0.0008): two of them underwent revision surgery. There was no difference in mean BCVA and microperimetry between patients experiencing or not a recurrence at M12. Conclusion Spontaneous ILM peeling is very common. Active ILM peeling prevents anatomical ERM recurrence but may induce retinal impairments and delay visual recovery. Trial Registration [NCT02146144][1]. All data relevant to the study are included in the article or uploaded as supplementary information. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02146144&atom=%2Fbjophthalmol%2F109%2F1%2F119.atom

中文翻译:


视网膜前膜手术期间内界膜剥离的利弊:显微视野计 (PEELING) 的随机临床试验



背景 去除特发性视网膜前膜 (iERM) 后,尚不清楚是否应去除内界膜 (ILM)。目的是评估 iERM 移除后活动性 ILM 脱皮是否可以诱发显微镜灶瘤。方法 PEELING 研究是一项全国性随机临床试验。当没有发生自发性 ILM 脱脱时,患者被随机分配到 ILM 脱脱组或无 ILM 脱脱组。在第 1 个月 (M1) 、 M6 和 M12 就诊时,根据显微视野计、最佳矫正视力 (BCVA) 和光学相干断层扫描结果对各组进行比较。主要结局是基线和 M6 之间显微暗点数的差异。结果 共纳入 213 例患者,其中 101 例出现自发性 ILM 脱皮,100 例被随机分配到 ILM 脱皮组 (n=51) 或无 ILM 脱皮组 (n=49)。两组显微镜暗点数量在 M1 时差异显著 (ILM 剥脱组多 3.9 个显微镜暗点,(0.8;7.0) p=0.0155),但在 M6 处没有 (ILM 剥脱组多 2.1 个微暗点 (-0.5;4.7) p=0.1155)。仅在无 ILM 脱皮组中,微暗点数量显著减少,平均视网膜敏感性显著提高。无 ILM 剥脱组 9 例患者 (19.6%) 的 ERM 复发,而 ILM 剥脱组为零 (p=0.0008):其中 2 例接受了翻修手术。在 M12 时复发或未复发的患者的平均 BCVA 和显微视野没有差异。结论 自发性 ILM 脱皮非常常见。主动 ILM 剥离可防止解剖学 ERM 复发,但可能会诱发视网膜损伤并延迟视力恢复。试验注册 [NCT02146144][1]。与研究相关的所有数据都包含在文章中或作为补充信息上传。 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02146144&atom=%2Fbjophthalmol%2F109%2F1%2F119.原子
更新日期:2024-12-18
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