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. 2023 Aug 7;2023(8):CD015031. doi: 10.1002/14651858.CD015031.pub2

NCT04698226.

Study name  
Methods Study design: single‐center parallel‐group RCT
Number randomized: 60 in total
Exclusions after randomization: none reported
Unit of analysis: NR
Handling of missing data: NR
Participants Country: Czechia
Inclusion criteria
  • Age > 18 years

  • Idiopathic FTMH verified on OCT (Gass stage 2–4)

  • Minimal MH size < 1000 um

  • Pseudophakia


Exclusion criteria
  • Presence of other ocular pathology influencing visual acuity (e.g. age‐related macular degeneration, diabetic retinopathy)

  • Unwillingness to sign the informed consent form

  • Inability to attend study visits

  • Health status not allowing participation in the study


Types of MH in the study: Idiopathic
Interventions Intervention: PPV with ILM inverted flap (type of inverted flap technique: "Flower petal" type)
Control: PPV with ILM peeling
Planned follow‐up: 6 months
Type of tamponade: SF6
Outcomes Primary outcomes
  • Near BCVA on Salzburg reading desk

  • Microperimetry – macular integrity

  • Microperimetry – average threshold

  • Microperimetry – fixation stability

  • MH closure rate


Secondary outcomes
  • Distance BCVA

  • Occurrence of perioperative complications at month 3 (e.g. retinal breaks)

  • Occurrence of postoperative complications at month 6 (e.g. intraocular hemorrhage, retinal detachment)


Time points of outcome measurement: 3 months (perioperative complications), 6 months
Starting date NR
Contact information Martin Pencak. Faculty Hospital Kralovske Vinohrady. Email: pencak@volny.cz
Notes Sponsorship source: Faculty Hospital Kralovske Vinohrady

BCVA: best‐corrected visual acuity; ERG: electroretinogram; FTMH: full‐thickness macular hole; ILM: internal limiting membrane; IOL: intraocular lens; MH: macular hole; NR: not reported; OCT: optical coherence tomography; PPV: pars plana vitrectomy; RCT: randomized controlled trial; SD: standard deviation; SD‐OCT: spectral domain optical coherence tomography.