A randomized clinical trial to compare inverted ILM flap technique and standard macular hole surgery in terms of anatomical and functional outcomes for macular holes diameter greater than 400 micron

Abstract

Aim: The aim of this is to evaluate the effects on vitrectomy with inverted internal limiting membrane (ILM) flap technique versus vitrectomy with complete ILM peeling (standard macular hole surgery) for large macular hole diameter greater than 400 micron.Design: A prospective, randomized clinical trialParticipants: patients with macular holes larger than 400 micron were included. In group A,75 eyes of 75 patients underwent standard macular hole surgery with complete ILM peeling. in group B,75 eyes of 75 patients underwent inverted ILM flap technique.Method: In the inverted ILM flap technique a remnant attached to the margins of the macular hole was left in place. This ILM remnant was then inverted upside down to cover the macular hole. Spectral domain optical coherence tomography and clinical examination were performed before surgery and postoperatively at 1, 3, 6 and12 months.Main outcome measures: visual acuity and macular hole closure.Results: Preoperative mean visual acuity was 0.0944 (Range 0.0630-0.1680) in group A and 0.0926 (range 0.0720-0.1430) in group B. macular hole closure was observed 93.33% of patients in group A, and in 100% of patients in group B, flat open was observed in 33.33% of patients in group A.13.33% of patients in group B. Mean postoperative visual acuity 12 months after surgery was 0.19 in group A and 0.31 in group B, (p value 0.001each) which was statistically significant.Conclusions: In the inverted ILM flap techniques prevents the postoperative flat open appearance of a macular hole and improves both the functional and anatomic outcomes of vitrectomy for macular holes with a diameter greater than 400 micron. Spectral optical coherence tomography after vitrectomy with the inverted ILM flap technique suggests improved foveal anatomy compared with the standard surgery.