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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Multiple Sclerosis
Glaucoma
Interventions Device: O-Glass
Other: Swinging Flashlight Test
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description 44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
Period Title: O-Glas Then SFT
Started 44
Completed 44
Not Completed 0
Period Title: SFT Then O-Glass
Started 44
Completed 44
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description 44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
35
(20 to 55)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
18
  40.9%
Male
26
  59.1%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Iran, Islamic Republic of Number Analyzed 44 participants
44
[1]
Measure Description: Khatam Al-Anbia Eye Hospital, Mashhad, a city in north east of Iran.
1.Primary Outcome
Title Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)
Hide Description

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.

Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title O-Glass Swinging Flashlight Test
Hide Arm/Group Description:
44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with O-Glass.
44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with manual swinging flashlight test(SFT).
Overall Number of Participants Analyzed 44 44
Measure Type: Number
Unit of Measure: participants
44 37
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description This diagnostic intervention is just an inspection and taking picture of the eye.
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/44 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amirhossein Vejdani
Organization: Mashhad University of Medical Sciences
Phone: +9151105411
EMail: amirhosein_vejdani@yahoo.com
Layout table for additonal information
Responsible Party: Amirhossein Vejdani, MD, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02772666    
Other Study ID Numbers: IR.MUMS.REC.1395.15
First Submitted: May 10, 2016
First Posted: May 13, 2016
Results First Submitted: July 14, 2016
Results First Posted: November 1, 2016
Last Update Posted: December 29, 2016