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

Velez‐Montoya 2018.

Study characteristics
Methods Study design: multicenter parallel‐group RCT
Number randomized
  • Total: 38 eyes of 38 participants

  • PPV with ILM inverted flap: 12

  • PPV with ILM peeling: 12

  • PPV with ILM free‐flap technique (not included in review): 14


Exclusions after randomization: no
Losses to follow‐up: NR
Unit of analysis: participant (1 eye per participant)
Number analyzed
  • Total: 38 eyes of 38 participants

  • PPV with ILM inverted flap: 12

  • PPV with ILM peeling: 12

  • PPV with ILM free‐flap technique (not included in review): 14


Handling of missing data: NR
Sample size calculation: NR
Participants Country: Mexico
Mean age
  • Total: NR

  • PPV with ILM inverted flap: 59.37 (SD 6.7) years

  • PPV with ILM peeling: 61.8 (SD 9.6) years


Gender
  • PPV with ILM inverted flap: NR

  • PPV with ILM peeling: NR


Mean preoperative BCVA in logMAR
  • Total: NR

  • PPV with ILM inverted flap: 0.925 (SD 0.5)

  • PPV with ILM peeling: 0.953 (SD 0.2)


Mean preoperative MH index in mm
  • Total: NR

  • PPV with ILM inverted flap: 0.47 (SD 1.01)

  • PPV with ILM peeling: 0.42 (SD 0.06)


Mean preoperative MH minimum diameter in mm
  • Total: NR

  • PPV with ILM inverted flap: 608.89 (SD 213)

  • PPV with ILM peeling: 522.22 (SD 82.73)


Mean preoperative MH base diameter in μm
  • Total: NR

  • PPV with ILM inverted flap: 993.67 (SD 484.21)

  • PPV with ILM peeling: 952.5 (SD 84.9)


Pseudophakia status: all eyes were phakic prior to the surgery in both groups
Inclusion criteria
  • Age ≥ 18 years

  • Treatment naivety

  • Clinical and tomographic diagnosis of stage IV large MH (minimum diameter > 400 μm)

  • Either sex and any BCVA at presentation, time of evolution, and lens status


Exclusion criteria
  • History of amblyopia, diabetic retinopathy, panretinal photocoagulation, glaucoma, inflammatory eye diseases, or high myopia (≥− 6)

  • Inability or refusal to sign informed consent form


Types of MH in the study: idiopathic
Equivalence of baseline characteristics: "There was no difference in age and time of evolution among groups (p= 0.58)"; " There were no differences in the MH closure rate between groups."
Interventions Intervention 1: PPV with ILM inverted flap (type of inverted flap technique: manipulated over the hole)
Intervention 2: PPV with ILM free‐flap technique (not included in review)
Control: PPV with ILM peeling
Cointerventions: "Cataract surgery in all cases (combined with vitrectomy)"
Follow‐up
  • Planned: 1 week, 1 month, and 3 months after surgery

  • Actual: 1 week, 1 month, and 3 months after surgery


Type of tamponade: none reported
Number of surgeons performing surgeries: 4 surgeons in 3 centers.
Outcomes Primary outcomes
  • Closure rate


Secondary outcomes
  • Change in BCVA (measured using Snellen visual acuity, which was converted to logMAR for statistical analysis)

  • OCT parameters


Safety outcomes: no cases of retinal detachment in any group
Time points of measurement: baseline, 1 month, 3 months
Notes Publication type: published article
Funding sources: "There were no funds allocated to the realization of this research."
Disclosures of interest: no conflicts of interest
Trial registry: none reported
Study period: 1 January 2016 to 1 January 2017
Subgroup analyses: no
Publication language: English

BCVA: best corrected visual acuity; ETDRS: early treatment diabetic retinopathy study; FTMH: full‐thickness macular hole; ILM: internal limiting membrane; logMAR: logarithm of the minimum angle of resolution; mfERG: multifocal electroretinogram; MH: macular hole; NR: not reported; OCT: optical coherence tomography; PPV: pars plana vitrectomy; RCT: randomized controlled trial; SD: standard deviation.