Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%
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.
Optic Neuropathy, Ischemic
Anterior Ischemic Optic Neuropathy
Ischemic Optic Neuropathy
Optic Neuropathy, Anterior Ischemic
Drug: Timolol maleate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.|
- Recruitment Rate of patients during the one year study to assess feasibility of a larger study [ Time Frame: 12 months ] [ Designated as safety issue: No ]This is to define the feasabilty of the study design for a larger study.
- Number of patients with adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
This group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks.
Drug: Timolol maleate
Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks.
No Intervention: Standard Care
This group will be treated with current standard care. This does not include Timolol or other medications to reduce intraocular pressure.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607671
|Canada, British Columbia|
|Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology|
|Surrey, British Columbia, Canada, V3T 0G9|
|Principal Investigator:||Martin A SuttonBrown, MD||Fraser Health Region|