COHORT SAFETY AND EFFICACY STUDY OF SILURON2000 EMULSIFICATION-RESISTANT SILICONE OIL AND F4H5 IN THE TREATMENT OF FULL-THICKNESS MACULAR HOLE.

Abstract

To evaluate safety and efficacy of using Siluron2000 silicone oil in the treatment of full-thickness macular hole by comparing its propensity to emulsify with emulsification of the "gold standard" Siluron5000, and to assess safety and efficacy of F4H5 (perfluorobutylpentane) in removing emulsified oil droplets from the eye. A single-center, randomized controlled parallel group trial in 72 patients undergoing vitrectomy for treatment of full-thickness macular hole. The study comprises four treatment groups. First, the total patient group was divided into 2 study arms of 36 patients each, receiving either Siluron2000 or Siluron5000 after vitrectomy with a 3-month follow-up after vitrectomy. Second, F4H5 was used during oil removal in half of the patients in each study arm (18 patients within each study arm) with follow-up at 6 weeks after oil removal. Oil droplets were counted within the removed oil; residual emulsification bubbles were quantified using ultrasound imaging. Safety and efficacy of the oils were comparable. Injection and removal time of Siluron2000 oil was significantly less than that of Siluron5000 oil. Patients treated with F4H5 had borderline significantly less emulsification droplets than those not treated with F4H5. Siluron2000 silicone oil seems to be equally safe and effective as Siluron5000 oil but allows for better handling with the potential of reducing procedure time. The application of F4H5 seems to be safe and effective in reducing residual emulsification.