Velez‐Montoya 2018.
| Study characteristics | |
| Methods |
Study design: multicenter parallel‐group RCT Number randomized
Exclusions after randomization: no Losses to follow‐up: NR Unit of analysis: participant (1 eye per participant) Number analyzed
Handling of missing data: NR Sample size calculation: NR |
| Participants |
Country: Mexico Mean age
Gender
Mean preoperative BCVA in logMAR
Mean preoperative MH index in mm
Mean preoperative MH minimum diameter in mm
Mean preoperative MH base diameter in μm
Pseudophakia status: all eyes were phakic prior to the surgery in both groups Inclusion criteria
Exclusion criteria
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
Type of tamponade: none reported Number of surgeons performing surgeries: 4 surgeons in 3 centers. |
| Outcomes |
Primary outcomes
Secondary outcomes
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.