Abstract：
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.
CONCLUSIONS: Spontaneous ILM peeling is very common. Active ILM peeling prevents anatomical ERM recurrence but may induce retinal impairments and delay visual recovery.
BACKGROUND: NCT02146144.
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.
CONCLUSIONS: Spontaneous ILM peeling is very common. Active ILM peeling prevents anatomical ERM recurrence but may induce retinal impairments and delay visual recovery.
BACKGROUND: NCT02146144.
摘要：
背景：特发性视网膜前膜（iERM）摘除后，目前尚不清楚是否应移除内界膜(ILM).目的是评估iERM去除后的主动ILM剥离是否会引起微暗点瘤。
方法：剥离研究是一项全国性的随机临床试验。当没有发生自发的ILM剥离时，患者被随机分为ILM剥离组或无ILM剥离组.在第1个月（M1）比较组，就显微视野而言，M6和M12就诊，最佳矫正视力（BCVA）和光学相干断层扫描结果。主要结果是基线和M6之间的微暗点数量差异。
结果：纳入213例患者，101例发生自发性ILM剥离，100例随机分为ILM剥离组（n=51）或无ILM剥离组（n=49）。两组之间的微暗点数量差异在M1时显着（ILM剥离组的微暗点多3.9，（0.8;7.0）p=0.0155），但在M6时则没有（ILM剥离组的微暗点增加2.1（-0.5;4.7）p=0.1155）。仅在无ILM剥离组中，微暗点数量显著减少,平均视网膜敏感度显著提高.无ILM剥离组中有9例患者（19.6％）复发，而ILM剥离组中为零（p=0.0008）：其中2例接受了翻修手术。M12复发或未复发的患者之间的平均BCVA和显微视野没有差异。
结论：自发性ILM剥离非常常见。主动ILM剥离可防止解剖ERM复发，但可能会引起视网膜损伤并延迟视力恢复。
背景：NCT02146144。
方法：剥离研究是一项全国性的随机临床试验。当没有发生自发的ILM剥离时，患者被随机分为ILM剥离组或无ILM剥离组.在第1个月（M1）比较组，就显微视野而言，M6和M12就诊，最佳矫正视力（BCVA）和光学相干断层扫描结果。主要结果是基线和M6之间的微暗点数量差异。
结果：纳入213例患者，101例发生自发性ILM剥离，100例随机分为ILM剥离组（n=51）或无ILM剥离组（n=49）。两组之间的微暗点数量差异在M1时显着（ILM剥离组的微暗点多3.9，（0.8;7.0）p=0.0155），但在M6时则没有（ILM剥离组的微暗点增加2.1（-0.5;4.7）p=0.1155）。仅在无ILM剥离组中，微暗点数量显著减少,平均视网膜敏感度显著提高.无ILM剥离组中有9例患者（19.6％）复发，而ILM剥离组中为零（p=0.0008）：其中2例接受了翻修手术。M12复发或未复发的患者之间的平均BCVA和显微视野没有差异。
结论：自发性ILM剥离非常常见。主动ILM剥离可防止解剖ERM复发，但可能会引起视网膜损伤并延迟视力恢复。
背景：NCT02146144。
