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Background <p>Idiopathic macular holes are commonly treated with pars plana vitrectomy and internal limiting membrane (ILM) peeling, which achieves high closure rates in smaller holes but is less effective for large or chronic cases. Alternative techniques, such as inverted or free flaps, may improve outcomes but often involve forceps manipulation, which can damage retinal tissue. The membrane loop device (FINESSE<sup>®</sup> Flex Loop; Alcon), designed for atraumatic manipulation of the ILM, has not been evaluated for giant flap creation. This study reports the anatomical and functional outcomes of macular hole repair using a giant ILM flap created exclusively with the membrane loop.</p> Methods <p>This prospective, single-arm interventional case series included patients with large (minimal linear diameter &gt; 400&#xa0;μm) or chronic (≥ 6 months) idiopathic macular holes. All underwent standard 25-gauge vitrectomy with creation of a 2–3&#xa0;mm ILM flap using the membrane loop without forceps. The primary endpoint was anatomical closure at day 14. Secondary outcomes included change in best-corrected visual acuity (ETDRS letters), proportion of eyes gaining ≥ 15 letters, and need for reoperation over six months.</p> Results <p>Eight eyes from eight patients (median age, 69 years; range, 45–77) were enrolled. Baseline median minimal linear diameter was 400&#xa0;μm, and median symptom duration was 11 months. Six of eight holes (75%) were closed after primary surgery, although one recurred after two months. The two eyes that were refractory and the one that recurred subsequently achieved closure after reoperation, resulting in a final closure rate of 100% at six months. Median visual acuity improved from 20 to 55 letters, corresponding to a gain of 33 letters (95% CI, + 5 to + 48; <i>P</i> = 0.018). Six eyes (75%) gained at least 15 letters, and no intraoperative or postoperative complications occurred.</p> Conclusions <p>Membrane loop-assisted giant ILM flap creation yielded a 75% primary and 100% final macular hole closure rate after reoperation, with consistent visual improvement in this pilot series of patients with large or chronic idiopathic macular holes. By minimizing retinal trauma and eliminating the need for forceps, this technique may represent a safe and effective surgical alternative. Larger, comparative studies are warranted to confirm these preliminary results, elucidate long-term anatomical and functional outcomes, and objectively quantify potential differences in retinal trauma relative to traditional forceps-assisted flap techniques.</p>

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Membrane flex loop-assisted peeling and giant flap creation for primary repair of idiopathic macular holes: a pilot study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月1日

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  • Rodrigo Jorge,
  • Victor Bellanda,
  • Arthur S. Zupelli,
  • Moises Moura de Lucena,
  • Letícia O. Audi,
  • Ingrid U. Scott,
  • Antonio Marcelo Barbante Casella

摘要

Background

Idiopathic macular holes are commonly treated with pars plana vitrectomy and internal limiting membrane (ILM) peeling, which achieves high closure rates in smaller holes but is less effective for large or chronic cases. Alternative techniques, such as inverted or free flaps, may improve outcomes but often involve forceps manipulation, which can damage retinal tissue. The membrane loop device (FINESSE® Flex Loop; Alcon), designed for atraumatic manipulation of the ILM, has not been evaluated for giant flap creation. This study reports the anatomical and functional outcomes of macular hole repair using a giant ILM flap created exclusively with the membrane loop.

Methods

This prospective, single-arm interventional case series included patients with large (minimal linear diameter > 400 μm) or chronic (≥ 6 months) idiopathic macular holes. All underwent standard 25-gauge vitrectomy with creation of a 2–3 mm ILM flap using the membrane loop without forceps. The primary endpoint was anatomical closure at day 14. Secondary outcomes included change in best-corrected visual acuity (ETDRS letters), proportion of eyes gaining ≥ 15 letters, and need for reoperation over six months.

Results

Eight eyes from eight patients (median age, 69 years; range, 45–77) were enrolled. Baseline median minimal linear diameter was 400 μm, and median symptom duration was 11 months. Six of eight holes (75%) were closed after primary surgery, although one recurred after two months. The two eyes that were refractory and the one that recurred subsequently achieved closure after reoperation, resulting in a final closure rate of 100% at six months. Median visual acuity improved from 20 to 55 letters, corresponding to a gain of 33 letters (95% CI, + 5 to + 48; P = 0.018). Six eyes (75%) gained at least 15 letters, and no intraoperative or postoperative complications occurred.

Conclusions

Membrane loop-assisted giant ILM flap creation yielded a 75% primary and 100% final macular hole closure rate after reoperation, with consistent visual improvement in this pilot series of patients with large or chronic idiopathic macular holes. By minimizing retinal trauma and eliminating the need for forceps, this technique may represent a safe and effective surgical alternative. Larger, comparative studies are warranted to confirm these preliminary results, elucidate long-term anatomical and functional outcomes, and objectively quantify potential differences in retinal trauma relative to traditional forceps-assisted flap techniques.