Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease (PCT)

July 6, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis confirmation is important to start proper treatment, because a NORB is often the first symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to define by a non-expert ophthalmologist.

The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to a large inter-individual variability, the dynamics of the pupillary light reflex and its latency are more reproducible. An easy way to study the dynamics of the pupillary light reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the conduction in the visual afferent pathways related to demyelination plate increases the latency of the pupillary light reflex and decreases the frequency of the PCT.

Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease in the frequency of the PCT in NORB, compared to the frequency observed in subjects ophthalmological or neurological disease, could help developing methods to study the conduction of the visual pathways with portable devices used during the standard ophthalmologic consultation and quickly orientate patients to specialized centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique A. De Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with no optic neuritis are recruited, to be compared with a database of 22 patients already recruited in a former study (measurement of pupillary light reflex already performed in that study, for the same purpose)

Description

Inclusion Criteria:

  • age > 18 years old
  • Subject without known ocular or neurological disease
  • Ametropia inferior to 3 diopters for spherical correction and inferior to 1.50 diopter for astigmatism correction
  • Matched for age and sex with one of the 22 subjects of the patients' unilateral NORB database

Exclusion Criteria:

  • history of disease affecting pupillary motility
  • anisocoria
  • patient under legal protection
  • pregnant or breast feeding patient
  • patient's refusal to participate in the study
  • no medical insurance coverage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Measure of pupillary light reflex
patients without optic neuritis
Device: pupillary light reflex
measure with infra-red cameras
patients with optic neuritis
clinical database of 22 patients (measurement of pupillary light reflex already performed for the same purpose, in a former study)
Device: pupillary light reflex
measure with infra-red cameras

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pupillary cycle time
Time Frame: baseline
Pupillary cycle time, measured in Hertz
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Cedric Lamirel, MD, Fondation OPH A de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 6, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL_2016_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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