ClearPath DS-120 Product Description

ClearPath DS-120 Lens Fluorescence Biomicroscope

The ClearPath DS-120 received 510(k) market clearance from the United States Food and Drug Administration,  effective January 31, 2013.

The ClearPath DS-120® Lens Fluorescence Biomicroscope is a  proprietary non-invasive ophthalmic tool designed to quickly detect autofluorescence of the crystalline lens. The ClearPath DS-120 device provides a quantitative result by rapidly measuring the intensity of auto fluorescence and scattering of light in the lens during a brief scan of the patient's eye at the point of care. This non-invasive bio-photonic approach represents a potential superior alternative to existing ophthalmic assessment tools by avoiding:

• Subjecting the patient to a painful blood draw or dialation of the eye
• The need for fasting prior to testing
• The inconvenience of waiting several days for the test result
• The production, hassle and cost of biohazard waste and disposal

The ClearPath DS-120 ophthalmic tool measurement cycle takes up to eight (8) seconds and features automatic pupil tracking of the eye. The result is available on the tablet display and can be printed out in hard copy form for the patient or clinician. The results can also be electronically transmitted to an electronic health records system or a referral healthcare provider. The device has been ergonomically designed to fit seamlessly into the practice with a choice of center room, left or right corner, on table or counter configurations.

For customers contemplating a ClearPath DS-120 for purchase, CLICK HERE to download a non-binding letter of interest that you can return to us.

Technical Specifications 

How It Works

The ClearPath DS-120 tool quantifies autofluorescence by rapidly measuring the intensity of the autofluorescence and the scattering of light in the lens during a brief scan of the patient's eye. The ClearPath DS-120 utilizes a scanning confocal reflectance microscope and eye-safe, long-life blue light emitting diodes (LEDs) to measure autofluorescence attributable to the lens of the eye. If the patient has a higher level of autofluorescence than what may be expected for their chronological age, the user of the tool may suggest a need for further patient assessment at his/her discretion. 

During normal use, the patient places his or her eye in front of the aperture of the instrument and fixates on a red blinking LED light. When the operator has aligned the patient's eye with the fixation target, a test can then begin. Upon the commencement of a test, a blue light shines on the patient's eye. A scan takes less than eight (8) seconds, and when internal software checks on the measurement’s validity are passed, a fluorescence ratio (labeled “Fluorescence”) is displayed along with a green dot next to the Quality metric, as shown in the Figure below. 

The result is available on the tablet display and can be printed out in hard copy form for the patient or clinician. The results can also be electronically transmitted to an electronic health records system or a referral healthcare provider.

The blue and green numeric values are presented in digital counts.  The scan begins behind the lens of the eye in the vitreous humor and an increase followed by a decrease in both the blue signal (scatter) and green signal (fluorescence) is seen as the sample volume passes through the lens. Immediately thereafter (<0.5sec), the software determines the front of the lens has been passed (and that the 1st scan has been completed), and the system reverses and performs a 2nd scan from the front of the lens and the test is completed.