Protocol: PON1 - Pediatric Optic Neuritis Prospective Outcomes Study
Status: Closed
Start Date: 07/01/2016
End Date:  
Clinical Trial ID: N/A
Public Dataset:  

Pediatric Optic Neuritis Prospective Outcomes Study

Protocol

Payment Schedule

Primary Aims:

  1. To determine our investigators' ability to enroll children with PON into a research protocol.
  2. To develop estimates of visual acuity outcomes in children with PON 6 months following enrollment.

Secondary Aims:

  1. To describe visual acuity outcomes at 1 month, 1 year, and 2 years after enrollment.
  2. To estimate the risk of an acute optic neuritis recurrence in the same eye at two years after enrollment.
  3. To estimate the risk of developing acute PON in the fellow eye at two years after enrollment for children with unilateral PON at presentation.
  4. To estimate the risk of diagnosis of MS 2 years after enrollment.
  5. To characterize PON including prevalence of white matter lesions on MRI and neuromyelitis optica (NMO) antibodies at enrollment.
  6. To determine retinal nerve fiber thickness and ganglion cell layer thickness  using spectral domain OCT at 1 month, 6 months, 1 year and 2 years after enrollment
  7. To collect MRIs for future analyses.
  8. To assess quality of life (QOL) outcomes using current pediatric instruments at 6 months.
  9. To describe low contrast visual acuity outcomes at 6 months, 1 year and 2 years after enrollment.

 



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