Frequently Asked Questions
Thank you for your interest in the objectiveFIELD Analyzer (OFA). The acquisition of this exciting new technology has very recently been completed and we are hard at work preparing to commercialize the device.
objectiveFIELD is FDA 510(k) Cleared and CE MARK activities have been initiated.
We will be updating the website as information becomes available.
In the meantime, we would be happy to add you to the OFA email list so that you are among the first to know about important updates / product availability. Please scroll to the bottom of this page and complete the form or call +1 (949) 576-2200.
It uses a novel stimulus strategy, an example of which you can see here. Pupillary responses are measured objectively using infrared video cameras.
The current full threshold test is approximately 7 mins for both eyes (binocular test).
It is objective, binocular, and very easy for patients to take and for techs to administer on patients. While it performs tests out to 30 degrees (29.5 degrees) and macular tests, OFA uses a completely different stimulus strategy – here is a link to a video of an example of what the patient sees. Responses are measured objectively using a patented “Clustered Volley”, multi-focal pupil objective perimetry method. ObjectiveField stimuli cover more than 99% of the 30-2 retinal area, while SAP Goldman III stimuli only sample approximately 0.5% of the 30-2 area with the assumption that the remaining 99.5% of the non-sampled central area is well represented by the small stimuli.
The HFA was the predicate device used in the FDA 510(K).
No. There are no disposable parts. Similar to many diagnostic devices, the forehead rest can be sanitized in between patients using alcohol wipes.
The human interface design is designed for a wide range of human morphology.
Trial lenses are used for larger refractive errors.
The device has not yet been commercialized, pricing and availability will be announced later this year.
| Fundamental Method
|| Multi-focal pupillographic objective perimetry
|Intended Clinical Purpose and Use
||Visual field examination to measure visual field defects
|Visual System Stimulus||Patented clustered volley, sparse, multifocal stimulus
||Video camera based pupil measurement
|Visual Function Assessment
||Regression based multifocal analysis
|Visual Field Defect Assessment
||Population sample normal database comparison|
||30°, 24° and macular test
||+3D, -3D, +6D, -6D, +9D, and -9D
|Regulatory||FDA 510(k) Cleared K063310