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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Glaucoma||Device: O-Glass Other: Swinging Flashlight Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||New Automatic Portable Ophthalmology Device|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
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.
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
- 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.
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
|Study Chair:||Amirhossein Vejdani, M.D.||Mashhad University of Medical Sciences|