Safety and efficacy of ulthera in the rejuvenation of aging lower eyelids: a pivotal clinical trial.

Abstract

The changes in the periorbital region are among the most prominent features of the aging process in the lower eyelids. Intense focused ultrasound (IFUS), known as the Ulthera System, was designed to correct this process. The current study assessed the safety and efficacy of the Ulthera System. This study enrolled seven adult patients who presented from March 2011 to May 2012 for correction of lower eyelid aging by Ulthera. The subjects were treated using Ulthera 1.5 and 3.0 mm probes. The 1.5 mm probe is used to tighten of loose eyelid skin and the deep dermis, whereas the 3.0 mm probe is used to tighten the orbicularis oculi muscle and the orbital septum. The patients were evaluated for allergic reactions and other side effects. The subjects' satisfaction with clinical photographs and the degree of pain were evaluated. Moreover, orbital computed tomography (CT) and ophthalmologic examinations were performed. The study used CT both as a research tool and as a clinical score system for evaluating aging lower eyelids and performed statistical analysis. Based on the CT images, the difference between the pre- and postoperative distances from the baseline (line between the most inferior point of the supraorbital rim and the most superior point of the infraorbital rim) to the most protruding point of the orbital septum was 0.51 ± 0.23 for the right eye (p < 0.001) and 0.54 ± 0.17 for the left eye (p < 0.001). The subjective score for patient satisfaction was 3.85 ± 0.69. The objective satisfaction scores reported by two blinded researchers were respectively 3.45 ± 1.69 and 3.25 ± 1.43. During the study period, no adverse events and no suspected serious adverse reactions were noted. Tightening of infraorbital laxity and skin can be achieved using the Ulthera System. Patients showed a minimal pain level during treatment, and topical analgesic cream was able to manage pain during the procedure.