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Purpose <p>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).</p> Methods <p>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, <i>n</i> = 14) or Group 2 (ILM flap, <i>n</i> = 11). BCVA, Optical coherence tomography (OCT), and microperimetry findings were compared.</p> Results <p>The closure rate was 100% and 81.8% in groups 1 and 2, respectively (<i>p</i> = 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 (<i>p</i> = 0.457). The fixation was higher in group 1 at baseline. Sensitivity (dB) results showed a significant difference at 12 months between groups (<i>p</i> = 0.029).</p> Conclusion <p>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.</p> <p>Clinicaltrials.gov 17 May 2021 (identifier: NCT04904679)</p>

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The use of amniotic membrane or inverted internal limiting membrane flap for large or refractory macular holes: a prospective, comparative study using microperimetry

  • 期刊论文

  • 发表日期：

    2025年9月15日

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  • Anna Carolina Carvalho Araujo,
  • Arnaldo F. Bordon,
  • Vinicius Falcão,
  • Patricia Bortolai,
  • Eduardo Dib,
  • Mauricio Maia

摘要

Purpose

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).

Methods

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.

Results

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).

Conclusion

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.

Clinicaltrials.gov 17 May 2021 (identifier: NCT04904679)