Clinical Trial: Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: New Automatic Portable Ophthalmology Device

Brief Summary: This study is to evaluate the ability of a newly designed device, Optic Nerve Glass (O-Glass) to detect relative afferent pupillary defect (RAPD). In this prospective study, 44 patients (diagnosed RAPD- positive) enrolled the study. They were examined for an RAPD by O-Glass and also manual swinging flashlight method (SFM) . This newly designed instrument captures and records eye pictures. The images will be processed and analyzed using computerized software to calculate pupillary measurements.

Detailed Summary: Pupil response to light stimulation is a basic clinical approach to the assessment of a patient with visual loss. Asymmetric response may indicate a relative afferent pupillary defect (RAPD). The rapid detection device for relative afferent pupillary defect (present device) is a newly designed portable facility with computerized software on a mobile device. This allows for field ophthalmic examination and identification of RAPDs quickly and accurately and also record pupillary movements for further processing and analysis or send the information and images via Wi-Fi. We aimed at comparing and evaluating this device with available methods to develop a test which is practically easy and quick with objective results and no need for specialist interpretation, so that any technician can perform the test automatically. Distinctive software allows simple use of the device by field personnel with minimal training. Each patient was investigated by swinging flashlight method and the newly constructed automated O-glass. The swinging flashlight test procedure, also called as Marcus Gunn Test, is well known in ophthalmology science.The hardware for this device includes 4 different parts: Camera and optics, light control system, power control system, and the microcontroller.The two main components of the software are the ability to communicate with the hardware wirelessly, and the pattern recognition system.
Sponsor: Mashhad University of Medical Sciences

Current Primary Outcome: Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD) [ Time Frame: up to 6 months ]

The instrument illuminated the eyes alternatively and took images and recorded pupillary reflex to this light stimulation.

All of 44 patients were examined with two methods, SFT and O Glass. SFT method: The well known manual method to diagnose RAPD. O glass method:The device consists of camera and light sources.The red light was on and off for a 5 second interval. Then the white light was on for right eye and 3 seconds later the system captured an image. After 0.5 second the right light was off and the left light turned on, 3 seconds later the image was captured. The images were processed and analyzed using computerized software.



Original Primary Outcome: Pupil size [ Time Frame: up to 6 months ]

The instrument illuminated the eyes alternatively and took images and recorded pupillary reflex to this light stimulation. The illumination was set at two colors: the white light for RAPD and the red light for Color Discrimination test (CDT). The red eye was on and off for a 5 second interval. Then the white light was on for right eye and 3 seconds later the system captured an image. After 0.5 second the right light was off and the left light turned on, 3 seconds later the image was captured. The images were processed and analyzed using computerized software.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mashhad University of Medical Sciences

Dates:
Date Received: May 10, 2016
Date Started: December 2015
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016