Multiple SclerosisNCT02772666
Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect
A study testing O-Glass and Swinging Flashlight Test in people with Multiple Sclerosis and Glaucoma, run by Mashhad University of Medical Sciences.
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 study, 44 patients (diagnosed RAPD- positive) enrolled the study. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Glaucoma
- What is being tested?
- O-Glass and Swinging Flashlight Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- positive relative afferent pupillary defect
Who cannot join
- -
About this study
Official title: New Automatic Portable Ophthalmology Device
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Glaucoma
- Being tested
- O-Glass, Swinging Flashlight Test
- Keywords
- Relative afferent pupillary defect (RAPD), Multiple sclerosis, Glaucoma
- Medical subject headings
- Multiple Sclerosis, Glaucoma, Pupil Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-GlassDevice
The new diagnostic device to distinguish relative afferent pupillary defect(RAPD).
Swinging Flashlight TestOther
Also called Other diagnostic method
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.
| Study group | Role | What they receive |
|---|---|---|
| O-Glass | Experimental | 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. Receives: Device: O-Glass |
| Swinging Flash light Test | Active comparator | 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. Receives: Other: Swinging Flashlight Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amirhossein Vejdani, MD, Mashhad University of Medical Sciences
- Investigators
- Amirhossein Vejdani, M.D., Study chair, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772666
- Sponsor's protocol ID
- IR.MUMS.REC.1395.15
- Status last verified
- Nov 2016
- First submitted
- 10 May 2016
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: I have not decided about it.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Automatic Portable Ophthalmology Device
- ClinicalTrials.gov ID
- NCT02772666
- Acronym / sponsor ID
- IR.MUMS.REC.1395.15
- Conditions
- Multiple Sclerosis, Glaucoma
- Keywords
- Relative afferent pupillary defect (RAPD), Multiple sclerosis, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 1 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O-Glass | Experimental | Device: O-GlassAll 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. |
| Swinging Flash light Test | Active comparator | Other: Swinging Flashlight TestAll 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- positive relative afferent pupillary defect
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O-GlassThe new diagnostic device to distinguish relative afferent pupillary defect(RAPD). | Device | O-Glass |
| Swinging Flashlight TestAlso: Other diagnostic methodThe 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 | Swinging Flash light Test |
Primary outcome
Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. I have not decided about it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amirhossein Vejdani, M.D. study chair
Mashhad University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing O-Glass and Swinging Flashlight Test in people with Multiple Sclerosis and Glaucoma, run by Mashhad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.