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Optic Neuritis and Ganglion Cell Layer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02864134
Enrollment
25
Registered
2016-08-11
Start date
2016-08-31
Completion date
2019-02-28
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Neuritis

Keywords

Optic neuritis, ganglion cell layer

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.

Interventions

None listed

Sponsors

CHU de Quebec-Universite Laval
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Association between the analysis of ganglion cells at diagnosis and the resulting visual acuity at 6 months after optic neuritis6 months post optic neuritisEvaluation 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.
Association between the analysis of ganglion cells at diagnosis and the visual function at 12 months after optic neuritis12 months post optic neuritisEvaluation 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026