PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Pilot Randomized Controlled Trial.

ABSTRACT

PURPOSE: To compare the functional and anatomical outcomes of peeled internal limiting membrane reposition and traditional internal limiting membrane peeling for the treatment of idiopathic macular hole. METHODS: This is a randomized, single-center, and double-blinded, pilot, controlled trial. RESULTS: Of the 30 patients enrolled, 27 (13 in Group 1 and 14 in Group 2) were included in the primary analysis (22 women [81.5%]; mean [SD] age, 61.7 [6.8] years). The BCVA was 0.23 ± 0.18 logMAR in the reposition group and 0.44 ± 0.24 logMAR in the peeling group at 6 months postoperatively (P = 0.02). The primary MH closure rate is 86.7% in the reposition group and 93.3% in the peeling group (P = 0.60). The range of the inner retinal dimpling was significantly lower in the reposition group at 6 months postoperatively (P < 0.0001). The thickness of the full parafovea (P = 0.0092), inner parafovea (P = 0.0007), inner perifovea (P = 0.0044), and outer fovea (P = 0.0392) was significantly greater in the reposition group than that in the peeling group at 6 months postoperatively. The sensitivity threshold and mfERG P1 wave amplitude density in rings one, four, and five were higher in the reposition group than in the peeling group at 6 months postoperatively. CONCLUSION: Our findings suggest that the novel technique of peeled internal limiting membrane reposition has advantages over the traditional internal limiting membrane peeling in better microstructural outcomes of inner retina and functional recoveries. Furthermore, larger RCT studies are warranted.