Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease

Optic Neuritis Clinical Trial

— PCT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894281
• Other study ID #: CLL_2016_2
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: July 6, 2017
• Start date: June 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Device:
• pupillary light reflex
measure with infra-red cameras

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupillary cycle time	Pupillary cycle time, measured in Hertz	baseline