Ophthalmology. Retina · 2025
Spontaneous Peeling of the Internal Limiting Membrane during Epiretinal Membrane Surgery: Lessons from the PEELING Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Eude Yannick, Poinas Alexandra, Volteau Christelle, Lebreton Olivier, Bonissent Alexandre, Fossum Paul, Creuzot-Garcher Catherine, Le Mer Yannick, Perol Julien, Fortin June, Jobert Alexandra, Billaud Fanny, Ivan Catherine, Weber Michel, Ducloyer Jean-Baptiste
Аннотация
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.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.