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

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02772666
• Collaborator: (none)
• Enrollment: 44
• Arms: 2
• Duration (Months): 6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Dec 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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 Names: Other diagnostic method

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• positive relative afferent pupillary defect

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mashhad University of Medical Sciences

Investigators

• Study Chair: Amirhossein Vejdani, M.D., Mashhad University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: Dec 29, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Amirhossein Vejdani, MD, Dr., Mashhad University of Medical Sciences: Relative afferent pupillary defect (RAPD); Multiple sclerosis; Glaucoma
• Additional relevant MeSH terms: Multiple Sclerosis; Pupil Disorders; Glaucoma; Sclerosis

Study Results

Participant Flow

Arm/Group Title	All Study Participants
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: O-Glas Then SFT
STARTED	44
COMPLETED	44
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
Overall Participants	44
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	35
Gender (Count of Participants)
Female	18 40.9%
Male	26 59.1%
Region of Enrollment (participants) [Number]
Iran, Islamic Republic of	44 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	O-Glass	Swinging Flashlight Test
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).
Measure Participants	44	44
Number [participants]	44 100%	37 NaN

Adverse Events

Time Frame	6 months
Arm/Group Title	All Study Participants
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.