Clinical Trial: Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer and Visual Field in Patients With an Acute Optic Neuritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) and Visual Field in Patients With a First Episode of Acute

Brief Summary:

Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days.

As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision.

There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage.

The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.


Detailed Summary:
Sponsor: Tehran University of Medical Sciences

Current Primary Outcome:

  • Retinal ganglion cell inner plexiform layer thickness in micrometer [ Time Frame: Measured at baseline ]
  • Retinal ganglion cell inner plexiform layer thickness in micrometer [ Time Frame: Measured after 1 month of treatment ]
  • Retinal ganglion cell inner plexiform layer thickness in micrometer [ Time Frame: Measured after 6 months of treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual field mean deviation in decibel [ Time Frame: Measured at baseline ]
  • Visual field mean deviation in decibel [ Time Frame: Measured at 1 month ]
  • Visual field mean deviation in decibel [ Time Frame: Measured at 6 months ]
  • Retinal nerve fibre layer thickness in micrometer [ Time Frame: Measured at baseline ]
  • Retinal nerve fibre layer thickness in micrometer [ Time Frame: Measured at 1 month ]
  • Retinal nerve fibre layer thickness in micrometer [ Time Frame: Measured at 6 months ]


Original Secondary Outcome: Same as current

Information By: Tehran University of Medical Sciences

Dates:
Date Received: August 8, 2016
Date Started: July 2016
Date Completion: July 2018
Last Updated: October 18, 2016
Last Verified: August 2016