Closure rate and recovery of subfoveal microstructures following conventional internal limiting membrane peeling versus per fluoro octane-assisted inverted flap for large macular holes – A randomized controlled trial (InFlap Study)

Abstract

Purpose: To analyze the outcomes following conventional internal limiting membrane (ILM) peeling versus perfluoro octane-assisted inverted flap technique for large macular holes (MH). Methods: A consecutive 99 eyes of 99 patients were enrolled {45 – conventional group and 54 – inverted flap (InFlap) group}. The primary outcome was a difference in closure rate. Secondary outcomes were differences in best-corrected visual acuity (BCVA), restoration of external limiting membrane (ELM) and ellipsoid zone (EZ) between groups at 3 (primary endpoint), 6 and 12 (secondary endpoints) months. Additionally, the effect of different gas tamponades on closure rates, ILM flap disintegration in InFlap group, and subfoveal thickness (SFT) between groups in closed. Results: At 3 months, there was no difference in the closure rate and BCVA between groups. At six months, closure rate was significantly better in the InFlap group. However, this difference was not maintained at 12 months. There was no difference in BCVA between groups at any visit. The ELM recovery was significantly higher in the conventional group at three months; however, there was no difference in ELM/EZ recovery between groups at other visits. The closure rate in the InFlap group was the same irrespective of gas tamponade. The ILM flap was identifiable in one-third of patients at 12 months. In closed MH, SFT was significantly more in InFlap group. Conclusion: The closure rate and visual outcomes remained similar in both groups in the immediate and long term. Conventional ILM peeling technique seems to have early ELM recovery when compared to inverted flap technique.