Optic Neuritis and Ganglion Cell Layer

Sponsor
CHU de Quebec-Universite Laval (Other)
Overall Status
Completed
CT.gov ID
NCT02864134
Collaborator
(none)
25
1
30.9
0.8

Study Details

Study Description

Brief Summary

BACKGROUND AND OBJECTIVES: The recent expansion of the applications of optical coherence tomography (OCT) demonstrated a higher correlation between the analysis of ganglion cells and visual function, in comparison with the analysis of the nerve fiber layer for several diseases of the optic nerve. Atrophy of the ganglion cells tends to induce the visual function deficits. In the case of optic neuritis, inflammation of the optic nerve causes a deficit of visual function initially with low vision, color blindness and visual field. Secondary atrophy of ganglion cell can result. The purpose of the study is to evaluate the correlation between the analysis of ganglion cells at the time of diagnosis of optic neuritis and the resulting visual acuity at 6 months and visual function (visual acuity, color vision and perimetry) 1 year regardless of treatment. A predictive effect could help predict the patient's clinical course and management of uncertainty and anxiety. MATERIALS AND METHODS: An assessment at diagnosis and follow-ups at 6 months and 1 year with a measurement of best corrected visual acuity, a test color vision HRR (Hardy-Rand-Rittler), an OCT with analysis of ganglion cells and perimetry Humphrey 30 -2 fast will be done. Simple linear and logistic regressions will be used. RESULTS: We expect that there will be a significant association between atrophy of ganglion cells in the diagnosis and residual visual function after an episode of optic neuritis. We believe that the initial atrophy is associated with poorer visual prognosis. CONCLUSION: A predictive effect could help to inform the patient about the evolution of the disease and provide early visual rehabilitation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predictive Effect of Ganglion Cell Layer on Visual Acuity at 6 Months and on Visual Function at 1 Year After an Episode of Optic Neuritis
    Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Feb 28, 2019
    Actual Study Completion Date :
    Feb 28, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Association between the analysis of ganglion cells at diagnosis and the resulting visual acuity at 6 months after optic neuritis [6 months post optic neuritis]

      Evaluation of best corrected visual acuity at 6 months post optic neuritis episode in correlation with initial ganglion cell layer analysis measures in order to predict the visual acuity in the future.

    2. Association between the analysis of ganglion cells at diagnosis and the visual function at 12 months after optic neuritis [12 months post optic neuritis]

      Evaluation of the visual function (best corrected visual acuity, perimetry, color vision) at 12 months post optic neuritis episode in correlation with initial ganglion cell layer analysis measures in order to predict the visual acuity in the future.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Major and apt patients seen in consultation with diagnosis of optic neuritis

    Exclusion Criteria:
    • Concomitant ophthalmic diseases

    • known macular pathology

    • Amblyopia

    • Glaucoma

    • History of an ophthalmic surgery

    • Family history of hereditary optic neuropathy

    • Pathological myopia (refractive error of 8 diopters or more).

    • Known neurological disease other than multiple sclerosis.

    • Habit

    • Nutritional deficiency anorexia, restrictive gastrointestinal surgery.

    • Active or former professional or recreational exposure

    • Exposure to metals: lead, mercury, thallium

    • Exposure to solvents: ethylene glycol, toluene, styrene, perchlorethylene;

    • Prior poisoning: methanol, carbon dioxide.

    • Usual or earlier Medication

    • Taking one or more drugs known to cause toxic optic neuropathy*

    • listed available on demand

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Saint-Sacrement Quebec Canada G1S 4L8

    Sponsors and Collaborators

    • CHU de Quebec-Universite Laval

    Investigators

    • Principal Investigator: Andréane Lavallée, MD, FRCSC, CHU de Québec-Laval University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andréane Lavallée, Ophthalmologist, CHU de Quebec-Universite Laval
    ClinicalTrials.gov Identifier:
    NCT02864134
    Other Study ID Numbers:
    • 2017-2916
    First Posted:
    Aug 11, 2016
    Last Update Posted:
    Jul 23, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Andréane Lavallée, Ophthalmologist, CHU de Quebec-Universite Laval
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 23, 2019