NCT02004054

Brief Summary

The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable symptom to evaluate in pathologies affecting the optic nerve

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

November 29, 2013

Last Update Submit

December 5, 2013

Conditions

Optic Neuritis

Keywords

multiple sclerosisdiameter pupil

Outcome Measures

Primary Outcomes (1)

  • Comparison between the PCT frequency of the eye affected by optic neuritis and a sane eye

    after 1h

Study Arms (1)

optic neurotis

measure of pupil diameter

Other: measure of pupil diameter

Interventions

measure of pupil diameterOTHER

The measure will use infra-red cameras

optic neurotis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with unilateral optic neuritis or with multiple sclerosis and an optic neuritis in the previous 5 years

You may qualify if:

  • patients with unilateral optic neuritis or with multiple sclerosis and an optic neuritis in the previous 5 years

You may not qualify if:

  • previous history of ophthalmic and neurologic pathology
  • anisocoria
  • minor
  • Patient with a measure of legal protection
  • Pregnancy
  • patient opposition to participation in the study
  • no affiliation to social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Optic NeuritisMultiple Sclerosis

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Cédric Lamirel

    Fondation Ophtalmologique Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 6, 2013

Study Start

December 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations

FR(1)