Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2025
The use of amniotic membrane or inverted internal limiting membrane flap for large or refractory macular holes: a prospective, comparative study using microperimetry.
Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04904679 (The Use of Amniotic Membrane or Inverted Internal Limiting Membrane Flap for Large or Refractory Macular Holes), which is not on this map. Not yet cited in PubMed.
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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
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6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo 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).
methodsIn 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.
resultsThe 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).
conclusionImprovement 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).
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