Optic Neuritis and Ganglion Cell Layer

NCT ID: NCT02864134

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Andréane Lavallée

Ophthalmologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andréane Lavallée, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec-Laval University

Locations

Hopital Saint-Sacrement

Québec, , Canada

Countries

Canada

Other Identifiers

2017-2916

Identifier Type: -

Identifier Source: org_study_id