Visual Field Device Approved For Use in the States
Seeing Machine, an Australian based firm received the blessing of the U. S. Food and Drug Administration to commence marketing of their TrueField Analyzer for evaluation of visual fields. The approval was detailed in a press release from the company.
The new device is unique in that it allows both eyes to be assessed simultaneously. The tool takes advantage of consensual light reflex, which improves the accuracy of assessment through consideration of bilateral assymetries. Throughout the test, patients are simply required to watch the display. The total time for evaluation is five minutes, which includes breaks so that the eyes can relax.
Pupil perimetry is measured by capturing changes to the pupil in response to visual stimulation of the retina. Regressive multi-focal methods are combined with advanced sparse stimuli and automated real-time computer vision pupil monitoring. Data collected from the testing is compared to a database containing data from subjects with normal peripheral vision.
The TrueField Analyzer overcomes some of the limitations of testing with standard automated perimetry (SAP). In particular, SAP tools assess the visual field of each eye separately. As well, SAP has been shown to have a number of issues in terms of reproducibility of findings, with variations in results from test to test. The TrueField, on the other hand, produces reliable and objective data.
Reports are prepared for clinicians in an easy to understand format. The report includes information on the patient’s pupil dynamics. That information includes responses to both direct and consensual stimulation, which may suggest an underlying neurological condition that requires evaluation.
The other advantage is that patients are not required to press a button each time a point is seen on the screen. This particular change may expand the number of patients who can undergo visual field assessment, as some may not be able to comply with that instruction.
Visual field measurement is an important ongoing evaluative technique for patients with glaucoma. Seeing Machine cites plans to commence marketing the product in the U.S. before the end of the year.
September 6, 2007 Related topics: Product Approval & Certification, Ophthalmology