Clinical Trial: Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.

Brief Summary: The purpose of this study is to evaluate the feasibility of rapid evaluation and administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the progression or improves recovery of patients who are randomly assigned to treatment versus standard of care.

Detailed Summary: Non-arteritic anterior ischemic optic neuropathy (NAION) currently has no widely accepted acute treatment to improve recovery or prevent progression in the first month. It causes monocular vision loss with potential second eye involvement in 15% at 5 years. This leads to significant disability. It is the most common acute optic neuropathy in patients over 55 years of age. The final mechanism of injury is believed to be ischemic. Increasing perfusion of the optic nerve may reduce damage and prevent progression. Reduction in intraocular pressure has been shown to increase optic disc perfusion in animal models. Timolol maleate is a widely used medication for Glaucoma that reduces intraocular pressure. Treatment with Timolol maleate may improve optic disc perfusion in NAION and reduce ischemic damage from this condition. This study aims to enroll and treat patients with Timolol maleate 0.5% within 48 hours of symptom onset to assess feasibility of the study design and potential benefit of rapid intraocular pressure reduction.
Sponsor: Fraser Health

Current Primary Outcome:

• Recruitment Rate of patients during the one year study to assess feasibility of a larger study [ Time Frame: 12 months ]
  This is to define the feasabilty of the study design for a larger study.
• Number of patients with adverse events [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in visual acuity at enrollment and three month follow up using a logMAR scale. [ Time Frame: Enrolment, Within 48 hours of enrollment , 1 month, 3 months. ]
  This will evaluate the change in visual acuity as a measure of visual function.
• Change in the mean deviation of actual versus predicted sensitivity of the visual field. [ Time Frame: 48 hours after enrollment, 1 month, 3 months ]
  Using a a Haag-Streit Octopus 900 with white on white TOP 30-2 visual field program, the mean deviation will be compared at various time points to assess for improving visual function as it relates to the field of vision.
• Change in Colour vision as measured by HRR colour plates. [ Time Frame: Within 48 hours of enrollment, 1 month, 3 months ]
  The total number of colour plates seen will be counted and compared to baseline as a measure of visual recovery as it effects colour vision.
• Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart. [ Time Frame: 48 hours from enrollment, 1 month, 3 months. ]
  The Pelli-Robson contrast sensitivity chart is another method to assess visual function. The change in total number of plates seen will be compared at the various time points.

Original Secondary Outcome: Same as current

Information By: Fraser Health

Dates:
Date Received: May 25, 2012
Date Started: June 2012
Date Completion:
Last Updated: May 22, 2015
Last Verified: May 2012