Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01607671|
Recruitment Status : Withdrawn (Unable to recruit participants from recruiting sites.)
First Posted : May 30, 2012
Last Update Posted : May 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Optic Neuropathy, Ischemic Anterior Ischemic Optic Neuropathy Ischemic Optic Neuropathy Optic Neuropathy, Anterior Ischemic||Drug: Timolol maleate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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.
- 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 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|