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

Manasa 2018.

Study characteristics
Methods Study design: single‐center parallel‐group RCT
Number randomized:
  • Total: 100 eyes of 100 participants

  • PPV with ILM inverted flap: 50

  • PPV with ILM peeling: 50


Exclusions after randomization: no
Losses to follow‐up
  • Total: 9 eyes

  • PPV with ILM inverted flap: 7

  • PPV with ILM peeling: 2


Unit of analysis: participant (1 eye per participant)
Number analyzed
  • Total: 91 eyes

  • PPV with ILM inverted flap: 43 eyes

  • PPV with ILM peeling: 48 eyes


Handling of missing data: complete‐case analysis
Sample size calculation: NR
Participants Country: India
Mean age
  • Total: 62.18 years

  • PPV with ILM inverted flap: 63.41 years

  • PPV with ILM peeling: 60.95 years


Gender
  • PPV with ILM inverted flap: 20/43 (46.5%) men and 23/43 (53.5%) women

  • PPV with ILM peeling: 22/48 (45.8%) men and 26/48(54.2%) women


Mean preoperative BCVA in logMAR
  • Total: NR

  • PPV with ILM inverted flap: 0.99

  • PPV with ILM peeling: 1.1


Mean preoperative MH index in mm
  • Total: NR

  • PPV with ILM inverted flap: 0.339 (SD 0.06)

  • PPV with ILM peeling: 0.34 (SD 0.05)


Mean preoperative MH minimum diameter in mm
  • Total: NR

  • PPV with ILM inverted flap: 673

  • PPV with ILM peeling: 657.5


Mean preoperative MH base diameter in μm (SD)
  • Total: NR

  • PPV with ILM inverted flap: NR

  • PPV with ILM peeling: NR


Pseudophakia status
  • PPV with ILM inverted flap: NR

  • PPV with ILM peeling: NR


Inclusion criteria
  • Idiopathic FTMH with minimum linear diameter ≥ 600 μm


Exclusion criteria
  • Traumatic MH

  • Associated ocular conditions (e.g. diabetic retinopathy, age‐related macular degeneration, high myopia, retinal detachment, glaucoma)


Types of MH in the study: idiopathic
Equivalence of baseline characteristics: yes: age, duration, preoperative visual acuity, minimum linear diameter, and MH index were comparable between groups.
Interventions Intervention: PPV with ILM inverted flap (type of inverted flap technique: the ILM flap was inverted and placed over the hole with a soft‐tipped cannula or a diamond‐dusted membrane scraper)
Control: PPV with ILM peeling
Cointerventions: NR
Follow‐up
  • Planned: 1 week, 1 month, 3 months

  • Actual: 1 week, 1 month, 3 months


Type of tamponade: 20% SF6 with air was left in the vitreous cavity. Postoperatively, face‐down positioning was prescribed for 3 days.
Number of surgeons performing surgeries: NR
Outcomes Primary outcomes
  • BCVA ("BCVA was measured using the standard ETDRS chart and converted to logMAR for statistical analysis.")

  • Postoperative MH closure


Secondary outcomes
  • mfERG


Safety outcomes: no postoperative complications or adverse events were reported.
Time points of measurement: 1 week, 1 month, 3 months
Notes Publication type: published article
Funding sources: none reported
Disclosures of interest: "The authors declare that they have no competing interests."
Trial registry: none reported
Study period: NR
Subgroup analyses: no
Publication language: English