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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Glaucoma Device: O-Glass Other: Swinging Flashlight Test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: New Automatic Portable Ophthalmology Device
Study Start Date : December 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.
Device: O-Glass
The new diagnostic device to distinguish relative afferent pupillary defect(RAPD).

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.
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




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • positive relative afferent pupillary defect

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772666


Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
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Study Chair: Amirhossein Vejdani, M.D. Mashhad University of Medical Sciences
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Responsible Party: Amirhossein Vejdani, MD, Dr., Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02772666    
Other Study ID Numbers: IR.MUMS.REC.1395.15
First Posted: May 13, 2016    Key Record Dates
Results First Posted: November 1, 2016
Last Update Posted: December 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: I have not decided about it.
Keywords provided by Amirhossein Vejdani, MD, Mashhad University of Medical Sciences:
Relative afferent pupillary defect (RAPD)
Multiple sclerosis
Glaucoma
Additional relevant MeSH terms:
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Multiple Sclerosis
Pupil Disorders
Glaucoma
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocular Hypertension
Eye Diseases
Neurologic Manifestations