TREATMENT OF PERSISTENTLY OPEN MACULAR HOLES WITH HEAVY SILICONE OIL (DENSIRON 68) VERSUS C2F6. A PROSPECTIVE RANDOMIZED STUDY.

Abstract

Abstract PURPOSE: To compare the efficacy of a mixture of silicone oil and perfluorohexyloctane (Densiron 68) with C2F6 gas endotamponade in the retreatment of persistently open full-thickness macular holes. METHODS: In this prospective randomized study, 21 consecutive patients who were unsuccessfully operated on for large idiopathic full-thickness macular hole were randomly assigned to undergo a second vitrectomy with 20% perfluoroethane gas (C2F6, Group A) or with Densiron 68 tamponade (Group B). PRIMARY OUTCOMES: Endpoint (12 months) full-thickness macular hole closure rate by spectral domain optical coherence tomography and logMAR corrected distance visual acuity. SECONDARY OUTCOMES: postoperative adverse events. RESULTS: The mean diameter of macular holes before the second pars plana vitrectomy was 680.3 ± 120.8 μm and 740.5 ± 105.3 μm in Groups A and B, respectively (P = 0.237); mean preoperative corrected distance visual acuity was 0.96 ± 0.36 logMAR and 1.12 ± 0.35 logMAR, respectively (P = 0.315). Endpoint full-thickness macular hole closure was obtained in 30% of patients (3/10) in Group A and in 82% (9/11) in Group B (P = 0.030). Corrected distance visual acuities were, respectively, 0.80 ± 0.25 logMAR and 0.55 ± 0.20 logMAR, with significant intergroup difference (P = 0.019); corrected distance visual acuity increased in Group B only (P = 0.003). No differences in complications were found. CONCLUSION: The results indicate that Densiron 68 tamponade could be a useful, safe, and more efficacious method than gas tamponade to retreat persisting macular holes.