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

NCT ID: NCT02772666

Last Updated: 2016-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis Glaucoma

Keywords

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Relative afferent pupillary defect (RAPD) Multiple sclerosis Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

O-Glass

Intervention Type DEVICE

The new diagnostic device to distinguish relative afferent pupillary defect(RAPD).

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.

Group Type ACTIVE_COMPARATOR

Swinging Flashlight Test

Intervention Type OTHER

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.

Interventions

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O-Glass

The new diagnostic device to distinguish relative afferent pupillary defect(RAPD).

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Other diagnostic method

Eligibility Criteria

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Inclusion Criteria

* positive relative afferent pupillary defect

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amirhossein Vejdani, MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amirhossein Vejdani, M.D.

Role: STUDY_CHAIR

Mashhad University of Medical Sciences

Other Identifiers

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IR.MUMS.REC.1395.15

Identifier Type: -

Identifier Source: org_study_id