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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02772666
• Other study ID #: IR.MUMS.REC.1395.15
• Status: Active, not recruiting
• Phase: N/A
• First received: May 10, 2016
• Last updated: May 12, 2016
• Start date: December 2015

Study information

• Verified date: May 2016
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Observational

Clinical Trial 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 observational study, 44 patients (diagnosed RAPD- positive) enrolled the study. Three groups of masked examiners observed patients for an RAPD by swinging flashlight method (SFM) and O-Glass. The instrument captured and recorded eye pictures. The images were processed and analyzed using computerized software to calculate pupillary measurements. The results were compared between two methods and three different groups of examiners. Twenty six patients were known cases of multiple sclerosis related optic neuritis, fourteen of them had glaucoma and four patients had history of traumatic optic neuropathy. The mean age (SD) of the study participants (18 female and 26 male) was 35. All three groups of examiners were satisfactory with successful diagnosis by O-Glass. Conclusion: O-Glass is a simple eye-glass along with mobile friendly software that any care giver can use to perform the tests to identify a RAPD automatically and rapidly. The ability to store and archive the objective and quantifiable results for referencing and follow-ups, makes the device more valuable.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• positive relative afferent pupillary defect

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diagnosis
• Glaucoma
• Multiple Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil size	The instrument illuminated the eyes alternatively and took images and recorded pupillary reflex to this light stimulation. The illumination was set at two colors: the white light for RAPD and the red light for Color Discrimination test (CDT). The red eye 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.	up to 6 months	No