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

Michalewska 2010.

Study characteristics
Methods Study design: single‐center parallel‐group RCT
Number randomized
  • Total: 101 eyes of 86 participants

  • PPV with ILM inverted flap: 50 eyes of 46 participants

  • PPV with ILM peeling: 51 eyes of 40 participants


Exclusions after randomization: no
Losses to follow‐up: none reported
Unit of analysis: eye
Number analyzed
  • Total: 101 eyes of 86 participants

  • PPV with ILM inverted flap: 50 eyes of 46 participants

  • PPV with ILM peeling: 51 eyes of 40 participants


Handling of missing data: NR
Sample size calculation: NR
Participants Country: Poland
Mean age
  • Total: 65.5 years

  • PPV with ILM inverted flap: 66 years

  • PPV with ILM peeling: 65 years


Gender
  • PPV with ILM inverted flap: 13/50 (28%) men and 33/50 (72%) women

  • PPV with ILM peeling: 8/51 (20%) men and 32/51 (80%) women


Mean preoperative BCVA in logMAR
  • Total: NR

  • PPV with ILM inverted flap: 1.1

  • PPV with ILM peeling: 0.92


Mean preoperative MH index in mm
  • Total: NR

  • PPV with ILM inverted flap: NR

  • PPV with ILM peeling: NR


Mean preoperative MH minimum diameter in mm
  • Total: NR

  • PPV with ILM inverted flap: 759 (range 415 to 1618)

  • PPV with ILM peeling: 698 (range 405 to 1126)


Mean preoperative MH base diameter in μm
  • Total: NR

  • PPV with ILM inverted flap: NR

  • PPV with ILM peeling: NR


Pseudophakia status
  • PPV with ILM inverted flap: 2/50 (4%)

  • PPV with ILM peeling: 4/51 (10%)


Inclusion criteria
  • Idiopathic FTMH with minimum diameter > 400 μm


Exclusion criteria
  • Severe retinal pathology (e.g. proliferative diabetic retinopathy, exudative age‐related macular degeneration, retinal detachment)


Types of MH in the study: idiopathic
Equivalence of baseline characteristics: yes: sex, age, minimum diameter, base diameter, and visual acuity were comparable between groups.
Interventions Intervention: PPV with ILM inverted flap (type of inverted flap technique: manipulated over the hole)
Control: PPV with ILM peeling
Cointerventions: "Cataract surgery in 9 patients (6 in group 1 and 3 in group 2) was performed during the time of this study (4–11 months after surgery)."
Follow‐up
  • Planned: 1 week, 1 month, 3 months, 6 months, 12 months

  • Actual: 1 week, 1 month, 3 months, 6 months, 12 months


Type of tamponade: air
Number of surgeons performing surgeries: 1
Outcomes Primary outcomes
  • Visual acuity (measured as mean BCVA using Snellen tables)

  • Postoperative MH closure


Secondary outcomes: not specified
Safety outcomes: no postoperative complications or adverse events were reported.
Time points of measurement: 1 week, 1 month, 3 months, 6 months, 12 months
Notes Publication type: published article
Funding sources: none reported
Disclosures of interest: "The author(s) have no proprietary or commercial interest in any materials discussed in this article."
Trial registry: none reported
Study period: NR
Subgroup analyses: no
Publication language: English