Comparative study of 1 DD and 2 DD radius conventional internal limiting membrane peeling in large idiopathic full-thickness macular holes: a randomized controlled trial.

Abstract

To compare the surgical outcomes of 1-disc diameter (DD) and 2-DD conventional internal limiting membrane peeling (C-ILMP) in large full-thickness macular holes (FTMHs). A prospective randomized controlled trial. One hundred patients with large idiopathic full-thickness macular hole (FTMH) were randomized into C-ILMP and extended C-ILMP (EC-ILMP) groups. The primary outcome was closure rate at 6 months after surgery. Secondary outcomes were visual acuity (VA), closure type, consequence of ILMP and complications. The mean symptom duration was 12.19 ± 9.64 months. Mean preoperative VA was 1.25 ± 0.37 logMAR. The average minimum linear diameter was 633.05 ± 129.82 µm and basal linear dimension was 1158.49 ± 249.07 µm. The two groups did not differ in term of demographic data. Closure rate was significantly higher in the EC-ILMP group (76.47% vs. 51.02%, 95% CI 7.24-43.66; p = 0.008). There were also no significant differences in closure type, central foveal thickness, dissociated optic nerve fibre layer detection, or change in fovea-to-disc distance. There were also no significant differences in postoperative VA (p = 0.069) or visual improvement (mean 0.39 ± 0.43 logMAR; p = 0.286). According to subgroup analysis, EC-ILMP resulted in a higher closure rate in patients with chronic FTMH for >6 months, (p = 0.008). Furthermore, EC-ILMP resulted in better anatomical closure and visual result in patients with FTMH with macular hole closure index ≤0.5, p = 0.003 and p = 0.010, respectively. Extended C-ILMP yielded a significantly higher closure rate in large FTMHs, but visual outcome did not differ significantly. According to subgroup analysis, extended C-ILMP was more effective in chronic large FTMH with MHCI ≤ 0.5.