Carvalho Araujo Anna Carolina, Bordon Arnaldo F, Falcão Vinicius, Bortolai Patricia, Dib Eduardo, Maia Mauricio
Retina and Vitreous Department, Hospital Oftalmológico de Sorocaba, Sorocaba, Brazil.
Ophthalmology Department, Vitreoretinal Surgery Unit, Federal University of Sao Paulo (UNIFESP/EPM), São Paulo, Brazil.
Graefes Arch Clin Exp Ophthalmol. 2025 Sep 15. doi: 10.1007/s00417-025-06917-3.
To compare microperimetry findings over one year following surgery for the treatment of large and/or refractory macular holes (MH) using human amniotic membrane (HAM) versus an internal limiting membrane (ILM) flap. Secondary endpoints included MH closure rates and best-corrected visual acuity (BCVA).
In this prospective, randomised, unmasked, single-centre study, 23 patients (25 eyes) with large (≥ 600 micrometers) or refractory MH were randomly assigned to Group 1 (HAM, n = 14) or Group 2 (ILM flap, n = 11). BCVA, Optical coherence tomography (OCT), and microperimetry findings were compared.
The closure rate was 100% and 81.8% in groups 1 and 2, respectively (p = 0.276). The mean BCVA was not significantly different at baseline and at the 12-month follow-up. At 12 months, 83.3% and 70% of eyes in groups 1 and 2, respectively, had stable fixation (p = 0.457). The fixation was higher in group 1 at baseline. Sensitivity (dB) results showed a significant difference at 12 months between groups (p = 0.029).
Improvement in macular sensitivity was not statistically better in the HAM group compared to the ILM flap group. Secondarily there was a significant improvement of BCVA in group 1 at month 12. The HAM surgery appears to be safe and effective for the treatment of large and refractory MH, showing good anatomical and functional outcomes.
gov 17 May 2021 (identifier: NCT04904679).
比较使用人羊膜（HAM）与内界膜（ILM）瓣治疗大的和/或难治性黄斑裂孔（MH）手术后一年的微视野检查结果。次要终点包括MH闭合率和最佳矫正视力（BCVA）。
在这项前瞻性、随机、非盲、单中心研究中，23例（25只眼）患有大的（≥600微米）或难治性MH的患者被随机分配到第1组（HAM，n = 14）或第2组（ILM瓣，n = 11）。比较BCVA、光学相干断层扫描（OCT）和微视野检查结果。
第1组和第2组的闭合率分别为100%和81.8%（p = 0.276）。基线时和12个月随访时的平均BCVA无显著差异。在12个月时，第1组和第2组分别有83.3%和70%的眼固定稳定（p = 0.457）。基线时第1组的固视较高。敏感度（dB）结果显示两组在12个月时有显著差异（p = 0.029）。
与ILM瓣组相比，HAM组黄斑敏感度的改善在统计学上并无更好。其次，第1组在第12个月时BCVA有显著改善。HAM手术对于治疗大的和难治性MH似乎是安全有效的，显示出良好的解剖和功能结果。
gov 2021年5月17日（标识符：NCT04904679）。
