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
Exclusion criteria
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
Secondary outcomes
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.