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

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ClinicalTrials.gov Identifier: NCT02772666
Recruitment Status : Completed
First Posted : May 13, 2016
Results First Posted : November 1, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Amirhossein Vejdani, MD, Mashhad University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE May 10, 2016
First Posted Date  ICMJE May 13, 2016
Results First Submitted Date  ICMJE July 14, 2016
Results First Posted Date  ICMJE November 1, 2016
Last Update Posted Date December 29, 2016
Study Start Date  ICMJE December 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
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 Measures  ICMJE
 (submitted: May 12, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect
Official Title  ICMJE 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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Multiple Sclerosis
  • Glaucoma
Intervention  ICMJE
  • Device: O-Glass
    The new diagnostic device to distinguish relative afferent pupillary defect(RAPD).
  • Other: Swinging Flashlight Test
    The swinging-flashlight test is used to help a practitioner identify a relative afferent pupillary defect.For an adequate test, vision must not be entirely lost. In dim room light, the examiner notes the size of the pupils. The patient is asked to gaze into the distance, and the examiner swings the beam of a penlight back and forth from one pupil to the other, and observes the size of pupils and reaction in the eye that is lit.
    Other Name: Other diagnostic method
Study Arms  ICMJE
  • Experimental: O-Glass
    All study participants who were diagnosed Relative Afferent Pupillary defect(RAPD) positive according to expert specialist investigations, were enrolled in this study. They were all examined with new device named O-Glass.
    Intervention: Device: O-Glass
  • Active Comparator: Swinging Flash light Test
    All study participants who were diagnosed Relative Afferent Pupillary defect(RAPD) positive according to expert specialist investigations were also examined with manual diagnostic method, Swinging Flash light Test(SFT). The standard and most common method for Marcus-Gunn test is Swinging Flashlight Test (SFT), which needs a dark room, and the patient will be asked to look toward a distant object, so the pupils are not focused. The patient is asked to gaze into the distance, and the examiner swings the beam of a penlight back and forth from one pupil to the other, and observes the size of pupils and reaction in the eye that is lit.
    Intervention: Other: Swinging Flashlight Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2016)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • positive relative afferent pupillary defect

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772666
Other Study ID Numbers  ICMJE IR.MUMS.REC.1395.15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: I have not decided about it.
Responsible Party Amirhossein Vejdani, MD, Mashhad University of Medical Sciences
Study Sponsor  ICMJE Mashhad University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Amirhossein Vejdani, M.D. Mashhad University of Medical Sciences
PRS Account Mashhad University of Medical Sciences
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP