Garcin Thibaud, Gaudric Alain, Sikorav Anne, Tadayoni Ramin, Couturier Aude
Ophthalmology Department, Hospital Lariboisiere and Fernand-Widal, Paris, France; Ophthalmology Department 5, National Hospital 15-20, Paris, France; University Jean Monnet, Saint-Etienne, France.
Ophthalmology Department, Hospital Lariboisiere and Fernand-Widal, Paris, France.
Ophthalmol Retina. 2025 Mar;9(3):253-262. doi: 10.1016/j.oret.2024.09.005. Epub 2024 Sep 12.
To evaluate the very long-term functional and structural outcomes of internal limiting membrane (ILM) peeling for full-thickness macular holes (FTMH).
Observational case series nested within a multicenter, randomized, controlled clinical trial (RCT) (ClinicalTrials.gov: NCT00190190).
Patients who underwent vitrectomy with or without ILM peeling for an idiopathic large FTMH in a tertiary ophthalmology center, with a minimum follow-up of 10 years after surgery.
Review of charts, spectral-domain OCT (SD-OCT) scans, OCT angiography (OCTA) scans, and microperimetry of patients originally enrolled in the RCT.
Primary outcome was functional assessment in both groups (ILM peeling or not) including the retinal sensitivity (RS), distance and near best-corrected visual acuity (BCVA), and number of eyes achieving ≥0.3 logarithm of the minimum angle of resolution >10 years after surgery. Secondary outcomes were structural assessment in the entire 3 × 3-mm and 6 × 6-mm areas, and regionally in the different areas of the ETDRS grid: OCT and OCTA biomarkers in both groups and fellow eyes.
Thirteen eyes of 13 patients with a mean follow-up of 12 ± 0.73 years were included. The mean RS and BCVA, or visual improvement did not differ between ILM peeling (n = 8) and no peeling (n = 5) (all P > 0.05). The dissociated optic nerve fiber layers on en face OCT were only observed in eyes with ILM peeling, predominantly in temporal parafoveal (20%) and perifoveal (19%) rings. The mean total retinal thickness and inner retinal thickness in the parafoveal ring were significantly lower in peeled eyes (309 ± 11 μm and 94 ± 9 μm respectively) versus nonpeeled eyes (330 ± 21 μm and 108 ± 11 μm respectively; P = 0.037 and P = 0.040), without significant difference in ganglion cell or retinal nerve fiber layers. Accordingly, the mean superficial capillary plexus density in the parafoveal ring was significantly lower in eyes with peeling versus without (39.65 ± 3.76% versus 47.22 ± 4.00; P = 0.005). The mean foveal avascular zone area was smaller in eyes with peeling versus without (0.24 ± 0.05 mm vs. 0.42 ± 0.13 mm, respectively, P = 0.005).
Despite persistent structural changes especially in the parafoveal ring, ILM peeling for idiopathic large FTMH did not seem to impact long-term RS or BCVA over 12 years.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
评估内界膜（ILM）剥除术治疗全层黄斑裂孔（FTMH）的超长期功能和结构预后。
嵌套于一项多中心、随机、对照临床试验（RCT）（ClinicalTrials.gov：NCT00190190）的观察性病例系列研究。
在一家三级眼科中心接受了玻璃体切除术（伴或不伴ILM剥除术）治疗特发性大FTMH的患者，术后至少随访10年。
回顾最初纳入RCT的患者的病历、频域光学相干断层扫描（SD-OCT）、光学相干断层扫描血管造影（OCTA）以及微视野检查结果。
主要结局是两组（ILM剥除组和未剥除组）的功能评估，包括视网膜敏感度（RS）、远视力和近视力的最佳矫正视力（BCVA），以及术后10年以上达到最小分辨角对数（logMAR）≥0.3的眼数。次要结局是对整个3×3mm和6×6mm区域以及ETDRS网格不同区域进行结构评估：两组及对侧眼的OCT和OCTA生物标志物。
纳入13例患者的13只眼，平均随访时间为12±0.73年。ILM剥除组（n = 8）和未剥除组（n = 5）之间的平均RS、BCVA或视力改善情况无差异（所有P>0.05）。仅在ILM剥除的眼中观察到OCT正面图像上的分离性视神经纤维层，主要位于颞侧黄斑旁（20%）和黄斑周围（19%）环。剥除组眼黄斑旁环的平均总视网膜厚度和视网膜内层厚度显著低于未剥除组（分别为309±11μm和94±9μm）（分别为330±21μm和108±11μm；P = 0.037和P = 0.040），神经节细胞层或视网膜神经纤维层无显著差异。因此，剥除组眼黄斑旁环的平均浅表毛细血管丛密度显著低于未剥除组（39.65±3.76%对47.22±4.00；P = 0.005）。剥除组眼的平均黄斑无血管区面积小于未剥除组（分别为0.24±0.05mm对0.42±0.13mm，P = 0.005）。
尽管存在持续的结构变化，尤其是在黄斑旁环，但特发性大FTMH的ILM剥除术在12年以上似乎并未影响长期RS或BCVA。
在本文末尾的脚注和披露中可能会找到专有或商业披露信息。
