Optic Neuritis and Ganglion Cell Layer

NCT02864134 | Completed DMC

• 1 other identifier: 2017-2916
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Neuritis

Keywords

Optic neuritis; ganglion cell layer

Outcome Measures

Primary Outcomes (2)

• Association between the analysis of ganglion cells at diagnosis and the resulting visual acuity at 6 months after 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.

  6 months post optic neuritis

• Association between the analysis of ganglion cells at diagnosis and the visual function at 12 months after 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.

  12 months post optic neuritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Hopital Saint-Sacrement

Québec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Optic Neuritis

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Andréane Lavallée, MD, FRCSC

  CHU de Québec-Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)