Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease

Completed

• Conditions: Optic Neuritis
• Interventions: Device: pupillary light reflex

• Registration Number: NCT02894281
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Measure of pupillary light reflex	pupillary light reflex	patients without optic neuritis
patients with optic neuritis	pupillary light reflex	clinical database of 22 patients (measurement of pupillary light reflex already performed for the same purpose, in a former study)

Primary Outcome Measures

Name	Time	Method
pupillary cycle time	baseline	Pupillary cycle time, measured in Hertz

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France