Comparative study of inverted internal limiting membrane (ILM) flap and ILM peeling technique in large macular holes: a randomized-control trial.

BACKGROUND: The anatomical success rate of macular hole surgery ranges around 93-98%. However, the prognosis of large macular holes is generally poor. The study was conducted to compare the anatomical and visual outcomes of Internal Limiting Membrane (ILM) peeling vis-a-vis inverted ILM flap for the treatment of idiopathic large Full-Thickness Macular Holes (FTMH).

METHODS: This was a prospective randomized control trial. The study included patients with idiopathic FTMH, with a minimum diameter ranging from 600 to 1500 μm. The patients were randomized into Group A (ILM peeling) and Group B (inverted ILM flap). The main outcome measures were anatomical and visual outcome at the end of 6 months. Anatomical success was defined as flattening of macular hole with resolution of the subretinal cuff of fluid and neurosensory retina completely covering the fovea.

RESULTS: There were 30 patients in each group. The mean minimum diameters in Group A and B were 759.97 ± 85.01 μm and 803.33 ± 120.65 μm respectively (p = 0.113). The mean base diameter in group A and B was 1304.50 ± 191.59 μm and 1395.17 ± 240.56 μm respectively (p = 0.112). The anatomical success rates achieved in Group A and B were 70.0 and 90.0% respectively (p = 0.125). The mean best-corrected visual acuity (BCVA) after 6 months was logMAR 0.65 ± 0.25 (Snellen equivalent, 20/89) in Group A and logMAR 0.53 ± 0.20 (Snellen equivalent, 20/68) in Group B (p = 0.060). The mean improvement in BCVA was 1.4 lines and 2.1 lines in groups A and B respectively (p = 0.353). BCVA≥20/60 was achieved by 13.3 and 20.0% in group A and B respectively (p = 0.766).

CONCLUSION: The anatomical and functional outcome of Inverted ILM flap technique in large FTMH is statistically similar to that seen in conventional ILM peeling.

TRIAL REGISTRATION: Clinical Trials Registry - India (Indian Medical Research) CTRI/2017/11/010474 .