- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02864134
Optic Neuritis and Ganglion Cell Layer
July 22, 2019 updated by: Andréane Lavallée, CHU de Quebec-Universite Laval
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1S 4L8
- Hopital Saint-Sacrement
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Major and apt patients seen in consultation with diagnosis of optic neuritis in emergency context
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between the analysis of ganglion cells at diagnosis and the resulting visual acuity at 6 months after optic neuritis
Time Frame: 6 months post optic neuritis
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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.
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6 months post optic neuritis
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Association between the analysis of ganglion cells at diagnosis and the visual function at 12 months after optic neuritis
Time Frame: 12 months post optic neuritis
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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.
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12 months post optic neuritis
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andréane Lavallée, MD, FRCSC, CHU de Québec-Laval University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
February 28, 2019
Study Completion (Actual)
February 28, 2019
Study Registration Dates
First Submitted
August 5, 2016
First Submitted That Met QC Criteria
August 10, 2016
First Posted (Estimate)
August 11, 2016
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-2916
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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