New Automatic Portable Ophthalmology Device

CompletedNot a drug-phase studyMS (type not specified)NCT02772666

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • O-Glass

Compared with

  • Swinging Flashlight Test

Results by group

Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)

up to 6 months

GroupValueIntervalNumber analysed
O-Glass44 participants44
Swinging Flashlight Test37 participants44

O-Glass

44

Swinging Flashlight Test

37

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
All Study Participants440 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)

    up to 6 months

Who could take part

MS (type not specified) · 20 to 55

Show the full criteria

Inclusion criteria

* positive relative afferent pupillary defect

Exclusion criteria

-

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Dec 2015

    2. Main results due

      May 2016

    3. Finished

      Jun 2016

    4. Results posted

      Nov 2016

    Assembled by software from public sources.