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NCT Number: NCT02864134

Optic Neuritis and Ganglion Cell Layer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Saint-Sacrement

Québec, G1S 4L8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2016
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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