Optic Neuritis and Ganglion Cell Layer

Optic Neuritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864134
• Other study ID #: 2017-2916
• Status: Completed
• Start date: August 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2019
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Neuritis
• Optic Neuritis

Locations

Country	Name	City	State
Canada	Hopital Saint-Sacrement	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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