PurposeTo evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults.MethodsThis was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments.ResultsA total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit.ConclusionThis study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score.
Education about EM practice matters including the risks of moonlighting should begin early in residency, because moonlighting is widespread. Residents are vulnerable to medicolegal action while moonlighting and have insufficient knowledge of their malpractice insurance coverage. Although educational debt is perceived as a strong motivating factor for moonlighting, there is only a weak relationship between educational debt and moonlighting hours.
Objectives: 1) To systematically describe emergency medicine (EM) program directors' perceptions of the benefits and risks of resident moonlighting. 2) To assess moonlighting policies of EM residencies, the degree of compliance with these policies, and the methods of dealing with residents who are out of compliance.Methods: A written survey was mailed or hand-delivered to all allopathic and osteopathic EM residency directors in the United States in 1992-93. Incomplete and ambiguous surveys were completed by phone.Results: There was a 96% response rate (113/118). The average EM resident clinical workweek ranged from 38 to 50 hours while the resident was assigned to ED rotations. Most (90%) of the program directors believe moonlighting interferes with residency duties to some degree. Few (10%) programs pFohibit moonlighting altogether, although 44% limit moonlighting to an average of 41.5 hours per month. Program directors believe residents moonlight primarily for financial reasons. Most (60%) of the program directors believe moonlighting offers experience not available in the residency, primarily related to autonomous practice. Fifteen programs reported residents who had been sued for malpractice while moonlighting, with one program director named along with the resident. One third of program directors have penalized residents for abuse of moonlighting privileges.Conclusions: EM residency directors are concerned about the effect of moonlighting on resident education. The directors' concerns regarding litigation, excessive work hours, and interference with residency duties are balanced by a general acceptance of the financial need to supplement residency income.
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