Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease

NCT02894281 | Completed

• 1 other identifier: CLL_2016_2
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Optic Neuritis

Keywords

Pupillary light reflex; Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• pupillary cycle time

  Pupillary cycle time, measured in Hertz

  baseline

Study Arms (2)

Measure of pupillary light reflex

patients without optic neuritis

Device: pupillary light reflex

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

Interventions

pupillary light reflex DEVICE

measure with infra-red cameras

Measure of pupillary light reflex; patients with optic neuritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Optic Neuritis; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Cedric Lamirel, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Study Start: June 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

FR (1)