Carl Zeiss Meditec has received FDA 510(k) Class II clearance for Humphrey Field Analyzer (HFA) II-i with Guided Progression Analysis (GPA) software. The automated perimeter comes with GPA software that has received clearance from the FDA to specifically assess the rate of visual field loss over time.
The FDA’s clearance letter for GPA software for the HFA stated that the product is ‘intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, glaucoma.’ GPA software also is available for the Cirrus HD-OCT.
With GPA, eye care providers can closely monitor vision changes for each individual patient to identify when visual field loss is progressing rapidly versus when loss has been stabilized by surgical or pharmacological intervention. Understanding each patient’s rate of progression allows eye care providers to adjust the therapeutic regimen in order to preserve vision.
Carl Zeiss said that GPA applies the same criteria used in the Early Manifest Glaucoma Trial to accurately determine which test points in the visual field have changed, and uses the new Visual Field Index (VFI) to measure the overall rate of visual field progression. GPA automatically summarizes all available visual field test results on a single page and calculates each patient’s rate of visual field deterioration.
The FDA 510(k) number K093213 indications for use states: “The Carl Zeiss Meditec, Guided Progression Analysis is a software module for the Humphrey Field Analyzer, that assists practitioners with the detection, measurement and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to glaucoma.”
Ludwin Monz, CEO of Carl Zeiss Meditec, said: “The Humphrey Field Analyzer has been the leading perimeter in the eye care industry for more than twenty-five years, and we are excited to have achieved another important milestone with the FDA’s clearance of GPA software. Our commitment to leadership in glaucoma continues as we seek to deliver technological enhancements that will allow practitioners to better detect and treat glaucoma, one of the leading causes of vision loss in the world.”