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Completed

NCT Number: NCT02894281

Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pupillary light reflex

Device

measure with infra-red cameras

Primary outcomes

  1. pupillary cycle time

    Time frame: baseline

    Pupillary cycle time, measured in Hertz

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: PCT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2016
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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