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CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS

Primary Purpose

Chronic Optic Neuropathy in Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
• Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Optic Neuropathy in Multiple Sclerosis focused on measuring optic neuritis, vision, quality of life, pathophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inclusion criteria for patients

    • All patients may have a clinically definite, laboratory-supported diagnosis of multiple sclerosis according to the Mac Donald criteria (2010).
    • All patients may present a chronic visual complaint.
    • All patients may present mild to moderate chronic optic neuropathy (cf infra)
    • All patients may not have recent acute optic neuritis (<2 years)
    • All patients will be informed about the design and purpose of the study, and all will give their informed, written consent to the protocol, which may have been approved by the local ethics committee.
    • Age: > 18
    • Able to understand the instructions
    • Having a health coverage
    • Able to sit down for 1 hour Diagnosis of mild to moderate chronic optic neuropathy

For the diagnosis of optic neuropathy, patients will have to meet 3 of the 6 next criteria:

  1. Far Visual Acuity (ETDRS charts, 100% contrast) < 85 letters
  2. Far Visual Acuity (ETDRS charts, 2.5% contrast) < 60 letters
  3. Mean visual field defect on static perimetry> 2dB
  4. Mean pRNFL in OCT < 80 µ.
  5. Color vision score > 35

  6. Disc pallor Diagnosis of mild to moderate optic neuropathy

    • Far Visual Acuity (ETDRS charts, 100% contrast) >70 letters Diagnosis of chronic optic neuropathy

    • Stable or worsening of visual acuity, visual field and/or RNFL in OCT, at 6 month of interval

      - Inclusion criteria for controls

    • Age > 18 years
    • Visual acuity score (ETDRS) > 85
    • Able to understand the instructions
    • Having a health coverage
    • Informed and consenting to give his written consent

Exclusion Criteria:

  • Non inclusion criteria for patients.

    • Ophthalmological

      • Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…)
      • Ocular instability in primary position of gaze

    • Neurological

      • Ongoing seizure
      • Severe handicap that does not allow sitting down position for 1 hour

    • General

      • Unstable medical state
      • Severe renal insufficiency
      • Allergy to gadolinium
      • Claustrophobia
      • Implanted electrical stimulator (pace maker)
      • Metallic prosthesis or orthesis, cochlear implants
      • Intraocular foreign material
    • Pregnancy (on questioning)
    • Tutelage or any legal protection measure

  • Non inclusion criteria for controls

    • Any ophthalmological disorder that could impair corrected visual acuity
    • Any neurological disorder
    • MRI contraindication
    • Allergy to gadolinium
    • Severe renal insufficiency
    • Claustrophobia
    • Implanted electrical stimulator (pace maker)
    • Metallic prosthesis or orthesis, cochlear implants
    • Intraocular foreign material
    • Pregnancy (on questioning)
    • Tutelage or any legal protection measure

Sites / Locations

  • Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

patients

Controls

Arm Description

patients with chronic optic neuropathy in multiple sclerosis

healthy volunteers

Outcomes

Primary Outcome Measures

Change from Day0 15' P100 VEP latency at one year
15' VEP latency may be the best outcome that allow differentiating patients from controls, and each of the sub-group of patients

Secondary Outcome Measures

Change from Day0 100%, 2.5% and 1.25% ETDRS Visual Acuity at one year (composite measure)
Change from Day0 Visual field macular threshold and corrected mean visual field deficit at one year (composite measure)
change frome Day0 NEI-VFQ 25 composite score and 10-item score at one year (composite measure)
Change from Day0 N75, P100, N135 VEP latency and amplitude; P50, N95 ERG latency and amplitude; p1 mERG latency and amplitude at one year (composite measure)
Change from Day0 OCT peripapillary RNLF thickness and Ganglion cell layer average thickness on macular dense volume at one year (composite measure)
MRI presence or absence of optic nerve inflammatory signs on diameter of the optic nerve

Full Information

First Posted
June 25, 2014
Last Updated
August 17, 2017
Sponsor
Hospices Civils de Lyon
Collaborators
Fondation pour la Recherche Médicale
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1. Study Identification

Unique Protocol Identification Number
NCT02543788
Brief Title
CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS
Official Title
CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS: DEMYELINATING AND/OR PRIMARY DEGENERATIVE PATHOPHYSIOLOGY?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
Fondation pour la Recherche Médicale

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON and P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage could be secondary to retrograde atrophy of axons within plaques of demyelination or a primary progressive degeneration of ganglion cells, but the underlying physiopathology has not been fully questioned in the different profile types of CON. In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON, i.e. secondary to demyelination or primary degeneration, in patients complaining of persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive neuro-ophthalmological assessment including clinical examination, visual evoked potentials (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve. In these patients with mild to moderate CON, investigators aim at differentiating patients showing predominant demyelination from those showing pure or predominant axonal degeneration. Visual function assessment and degree of axonal degeneration will be compared and correlated in the two types of underlying pathophysiology and in the group of control subject. In a following longitudinal study, the patients will be re-assessed a year later in order to evaluate the progression of CON in both profile types. Our hypothesis would be that visual function and progression is worse in the degeneration group as compared to the demyelination group. This study should help to find reliable measures of the pathophysiology of CON and correlate it with the long-term visual prognostic of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Optic Neuropathy in Multiple Sclerosis
Keywords
optic neuritis, vision, quality of life, pathophysiology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Other
Arm Description
patients with chronic optic neuropathy in multiple sclerosis
Arm Title
Controls
Arm Type
Other
Arm Description
healthy volunteers
Intervention Type
Procedure
Intervention Name(s)
• Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG
Primary Outcome Measure Information:
Title
Change from Day0 15' P100 VEP latency at one year
Description
15' VEP latency may be the best outcome that allow differentiating patients from controls, and each of the sub-group of patients
Time Frame
D0 and one year
Secondary Outcome Measure Information:
Title
Change from Day0 100%, 2.5% and 1.25% ETDRS Visual Acuity at one year (composite measure)
Time Frame
D0 and one year
Title
Change from Day0 Visual field macular threshold and corrected mean visual field deficit at one year (composite measure)
Time Frame
D0 and one year
Title
change frome Day0 NEI-VFQ 25 composite score and 10-item score at one year (composite measure)
Time Frame
D0 and one year
Title
Change from Day0 N75, P100, N135 VEP latency and amplitude; P50, N95 ERG latency and amplitude; p1 mERG latency and amplitude at one year (composite measure)
Time Frame
D0 and one year
Title
Change from Day0 OCT peripapillary RNLF thickness and Ganglion cell layer average thickness on macular dense volume at one year (composite measure)
Time Frame
D0 and one year
Title
MRI presence or absence of optic nerve inflammatory signs on diameter of the optic nerve
Time Frame
D0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for patients All patients may have a clinically definite, laboratory-supported diagnosis of multiple sclerosis according to the Mac Donald criteria (2010). All patients may present a chronic visual complaint. All patients may present mild to moderate chronic optic neuropathy (cf infra) All patients may not have recent acute optic neuritis (<2 years) All patients will be informed about the design and purpose of the study, and all will give their informed, written consent to the protocol, which may have been approved by the local ethics committee. Age: > 18 Able to understand the instructions Having a health coverage Able to sit down for 1 hour Diagnosis of mild to moderate chronic optic neuropathy For the diagnosis of optic neuropathy, patients will have to meet 3 of the 6 next criteria: Far Visual Acuity (ETDRS charts, 100% contrast) < 85 letters Far Visual Acuity (ETDRS charts, 2.5% contrast) < 60 letters Mean visual field defect on static perimetry> 2dB Mean pRNFL in OCT < 80 µ. Color vision score > 35 Disc pallor Diagnosis of mild to moderate optic neuropathy Far Visual Acuity (ETDRS charts, 100% contrast) >70 letters Diagnosis of chronic optic neuropathy Stable or worsening of visual acuity, visual field and/or RNFL in OCT, at 6 month of interval - Inclusion criteria for controls Age > 18 years Visual acuity score (ETDRS) > 85 Able to understand the instructions Having a health coverage Informed and consenting to give his written consent Exclusion Criteria: Non inclusion criteria for patients. Ophthalmological Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…) Ocular instability in primary position of gaze Neurological Ongoing seizure Severe handicap that does not allow sitting down position for 1 hour General Unstable medical state Severe renal insufficiency Allergy to gadolinium Claustrophobia Implanted electrical stimulator (pace maker) Metallic prosthesis or orthesis, cochlear implants Intraocular foreign material Pregnancy (on questioning) Tutelage or any legal protection measure Non inclusion criteria for controls Any ophthalmological disorder that could impair corrected visual acuity Any neurological disorder MRI contraindication Allergy to gadolinium Severe renal insufficiency Claustrophobia Implanted electrical stimulator (pace maker) Metallic prosthesis or orthesis, cochlear implants Intraocular foreign material Pregnancy (on questioning) Tutelage or any legal protection measure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline TILIKETE, MD
Organizational Affiliation
Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON
City
France
State/Province
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

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CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS

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