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Internal Limiting Membrane Peeling for Large Macular Holes : Structural and Functional results at 12-years follow-up from a Nested Cohort within a randomized, multicentric, and controlled clinical trial

The benefit of internal limiting membrane (ILM) peeling for the anatomic closure rate of full-thickness macular holes (FTMH) >400 µm have been proven by several studies. However, its very long term structural and functional outcomes were less studied. We aim to determine the anatomic and functional outcomes of ILM peeling compared to no-peeling more than 10 years after surgery. 

Monocentric nested cohort within an interventional, controlled, randomized, multicentric registered at ClinicalTrials.gov (Identifier: NCT00190190), including 13 eyes after closure of an idiopathic FTMH. Spectral domain optical coherence tomography (SD-OCT), OCT-angiography (OCT-A) (3x3mm, 6x6mm), scanning laser ophthalmoscopy microperimetry (SLOmp) (4-2 strategy, 6° central, stimuli duration 200ms) were performed. The ILM was peeled in 8/13 eyes. The mean follow-up period was 12 ±0.73 years. The main outcome measurement was retinal sensitivity and visual acuity (far, near, EDTRS). Secondary outcomes were: superficial capillary plexus (SCP) and deep capillary complex (DCC) densities, foveal avascular zone (FAZ) area and perimetry, total retinal thickness (TRT) & inner retinal thickness (IRT), and other parameters provided by SLOmp, and QALY.

The mean retinal sensitivity and mean visual acuity did not differ between the 8 eyes operated with ILM peeling and the 5 eyes with no-peeling technique (all p>0.05). The mean SCP density was significatively lower in the eyes with peeling versus without in the parafoveal ring (0.5-1.5mm radius), 3x3mm and 6x6mm cubes: respectively, 36.58 ±3.29 % vs. 43.38 ±4.93 (p=0.012), 34.81 ±3.92 % vs. 40.00 ±4.36 (p=0.032) and 40.14 ±4.26 % vs. 45.65±2.65 (p=0.026). The mean FAZ area & perimetry were smaller after peeling : 0.244 ±0.049 mm2 with peeling vs. 0.422 ±0.134 without (p=0.005), and 1.995 ±0.236 mm2 vs. 2.572 ±0.467 (p=0.012) respectively. The dissociated optic nerve-fiber layers (DONFL) were only observed in peeled eyes (100%, n=8), predominantly in temporal parafoveal (21%) and temporal perifoveal (19%) rings. Mean TRT was lower after peeling in parafoveal ring: 308.88 ±11.44 µm with peeling vs. 333.65 ±18.42 without (p=0.015). Regarding DCC density and IRT globally or in different part of the rings, no significant differences were noted between ILM peeling and the no-peeling technique.

ILM peeling may only change some structural outcomes in the foveola, but also in parafoveal and perifoveal rings, highlighting long-lasting mechanical remodeling. These results suggest that ILM peeling may not influence functional outcomes such as visual acuity or retinal sensitivity more than 10 years after surgery. 

Even if ILM peeling may induce long-lasting structural remodeling with predominant temporal DONFL and OCTA parameters as lower SCP density, FAZ area & perimetry, and TRT ; it seems not  to influence functional outcomes more than 10-year after surgery.