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

Mashhad University of Medical Sciences

Status: Completed

Conditions: Multiple Sclerosis; Glaucoma

Treatments: Device: O-Glass; Other: Swinging Flashlight Test

Study type: Interventional

Funder types: Other

Identifiers

NCT02772666

IR.MUMS.REC.1395.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• positive relative afferent pupillary defect

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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44 participants in 2 patient groups

O-Glass

Experimental group

Description:

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.

Treatment:

Device: O-Glass

Swinging Flash light Test

Active Comparator group

Description:

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.

Treatment:

Other: Swinging Flashlight Test