BackgroundThe 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).
MethodsThis was a prospective randomized control trial. The study included patients with idiopathic FTMH, with a minimum diameter ranging from 600 to 1500 ?m. 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.
ResultsThere were 30 patients in each group. The mean minimum diameters in Group A and B were 759.97?±?85.01 ?m and 803.33?±?120.65 ?m respectively (p?=?0.113). The mean base diameter in group A and B was 1304.50?±?191.59 ?m and 1395.17?±?240.56 ?m 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).
ConclusionThe anatomical and functional outcome of Inverted ILM flap technique in large FTMH is statistically similar to that seen in conventional ILM peeling.
Trial registrationClinical Trials Registry - India (Indian Medical Research) CTRI/2017/11/010474 .