Citations

AbstractPurposeEye plaques are widely used for ocular melanoma and provide an effective alternative to enucleation with adequate tumor control. A COMS plaque utilizes a Silastic insert for precise positioning of the radioactive seeds with respect to the scleral surface of the eye; however, due to manufacturing variability, the insert may unintentionally increase or decrease the distance between the sources and tumor. The purpose of this work is to provide guidance in measuring and identifying outliers in Silastic inserts. The importance of regular quality assurance (QA) is illustrated in an experience where a systematic problem was detected and the manufacturer's 22‐mm mold was corrected.MethodsA detailed description of the molds and manufacturing process used to produce Silastic inserts is provided, including photographs of the process steps. The variability in Silastic insert production was evaluated by measuring the thickness of 124 Silastic inserts. An estimate of how the observed Silastic thickness discrepancies impact the dose to the tumor and critical eye structures was performed using homogeneous dose calculations. A standard QA protocol was developed to guide the clinical user.ResultsThickness of the measured Silastic inserts ranged from 1.22 to 2.67 mm, demonstrating variation from the 2.25 mm standard. Six of the 22‐mm inserts were outliers (Δthickness >3 standard deviations) and were excluded from the statistics. The outliers were investigated with the help of the manufacturer, who discovered that a systematic error was accidentally introduced into the 22‐mm mold.ConclusionsDue to manufacturing errors or variability, the Silastic inserts used in COMS eye plaques may be thicker or thinner than the design standard. Such variations may impact tumor control or increase the risk of normal tissue side effects. A standardized QA program is recommended to detect variations and communicate unusual findings to the manufacturer.

A 24 mm COMS‐like eye plaque was developed to meet the treatment needs of our eye plaque brachytherapy practice. As part of commissioning, it was necessary to determine the new plaque's seed coordinates. The FARO Edge, a commercially available measurement arm, was chosen for this purpose. In order to validate the FARO Edge method, it was first used to measure the seed marker coordinates in the silastic molds for the standard 10, 18, and 20 mm COMS plaques, and the results were compared with the standard published Task Group 129 coordinates by a nonlinear least squares match in MATLAB version R2013a. All measured coordinates were within 0.60 mm, and root mean square deviation was 0.12, 0.23, and 0.35 mm for the 10, 18, and 20 mm molds, respectively. The FARO Edge was then used to measure the seed marker locations in the new 24 mm silastic mold. Those values were compared to the manufacturing specification coordinates and were found to demonstrate good agreement, with a maximum deviation of 0.56 mm and a root mean square deviation of 0.37 mm. The FARO Edge is deemed to be a reliable method for determining seed coordinates for COMS silastics, and the seed coordinates for the new 24 mm plaque are presented.PACS number: 87.53.Jw