Internal Limiting Membrane Peeling Versus Inverted Flap Technique for Treatment of Idiopathic Full-thickness Macular Hole: a Comparative Study of Near Visual Acuity Outcomes Using Salzburg Reading Desk.

Idiopathic full-thickness macular hole (MH) is an anatomic defect of the macula caused by the traction of the vitreous. Interruption of all neural retinal layers from the internal limiting membrane (ILM) to the retinal pigment epithelium (RPE) is present. Although other therapeutic approaches like pneumatic or enzymatic vitreolysis may lead to MH closure, pars plana vitrectomy (PPV) remains a gold standard for the treatment of full-thickness MH. Combination of PPV with full ILM peeling showed excellent results in small to medium MH, however the success rates dropped significantly with the increasing size of MH. PPV with inverted flap technique was introduced to address this issue and showed great results in MH of all diameters. In inverted flap technique, ILM is peeled around the MH and small piece of it is placed over the MH. It is speculated, that it serves as a scaffolding for gliosis allowing it to close large MHs. Besides gliosis, the ILM flap seals the MH by secluding communication between the vitreous and subretinal space, creating a closed compartment enabling the RPE to pump out fluid effectively. However, it is not known whether the ILM left in the macular hole might not hinder the healing process and full closure of macular hole. The aim of this study is to perform a detailed assessment of the state of the macula and near best corrected visual acuity and to compare the results of complete ILM peeling and ILM flap technique.

This is a prospective randomised study comparing the near visual acuity outcomes using Salzburg Reading Desk in pseudophakic patients with idiopathic full-thickness MH treated with PPV with ILM peeling versus inverted flap technique. Participants are randomized in a 1:1 ration to undergo 25-gauge PPV with complete ILM peeling or with circular inverted flap technique with sulphur hexafluoride as a tamponade and recommendation to maintain reading position for 3 days.

At baseline visit (D1) one day prior to the operation, patients undergo distance best corrected visual acuity (BCVA) exam using ETDRS charts, intraocular pressure (IOP) measuring using the non-contact tonometry, anterior segment slit-lamp examination, fundus biomicroscopy, microperimetry and optical coherence tomography (OCT).

At month 3 (M3) and month 6 (M6) visits, patients undergo distance BCVA exam using ETDRS charts, near BCVA exam using the Salzburg reading desk (SRD Vision, NY, USA), IOP measuring using the non-contact tonometry, anterior segment slit-lamp examination, fundus biomicroscopy, microperimetry, and OCT. The closure of macular hole and post-operational complications are assessed.

Distance BCVA is performed using ETDRS charts and recorded in logMAR.