Trial Outcomes & Findings for Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect (NCT NCT02772666)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

up to 6 months

Results posted on

2016-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants 44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
O-Glas Then SFT STARTED	44
O-Glas Then SFT COMPLETED	44
O-Glas Then SFT NOT COMPLETED	0
SFT Then O-Glass STARTED	44
SFT Then O-Glass COMPLETED	44
SFT Then O-Glass NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=44 Participants 44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
Age, Continuous	35 years n=5 Participants
Gender Female	18 Participants n=5 Participants
Gender Male	26 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	O-Glass n=44 Participants 44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with O-Glass.	Swinging Flashlight Test n=44 Participants 44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with manual swinging flashlight test(SFT).
Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)	44 participants	37 participants

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amirhossein Vejdani

Mashhad University of Medical Sciences

Phone: +9151105411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place