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Unable to recruit participants from recruiting sites.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol | Experimental | This group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks. |
|
| Standard Care | No Intervention | This group will be treated with current standard care. This does not include Timolol or other medications to reduce intraocular pressure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol maleate | Drug | Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate of patients during the one year study to assess feasibility of a larger study | This is to define the feasabilty of the study design for a larger study. | 12 months |
| Number of patients with adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual acuity at enrollment and three month follow up using a logMAR scale. | This will evaluate the change in visual acuity as a measure of visual function. | Enrolment, Within 48 hours of enrollment , 1 month, 3 months. |
| Change in the mean deviation of actual versus predicted sensitivity of the visual field. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin A SuttonBrown, MD | Fraser Health Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology | Surrey | British Columbia | V3T 0G9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20006051 | Background | Atkins EJ, Bruce BB, Newman NJ, Biousse V. Treatment of nonarteritic anterior ischemic optic neuropathy. Surv Ophthalmol. 2010 Jan-Feb;55(1):47-63. doi: 10.1016/j.survophthal.2009.06.008. | |
| 8361399 | Background | Glucksberg MR, Dunn R. Direct measurement of retinal microvascular pressures in the live, anesthetized cat. Microvasc Res. 1993 Mar;45(2):158-65. doi: 10.1006/mvre.1993.1015. |
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| ID | Term |
|---|---|
| D018917 | Optic Neuropathy, Ischemic |
| D007511 | Ischemia |
| D009901 | Optic Nerve Diseases |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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. |
| 48 hours after enrollment, 1 month, 3 months |
| Change in Colour vision as measured by HRR colour plates. | 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. | Within 48 hours of enrollment, 1 month, 3 months |
| Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart. | 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. | 48 hours from enrollment, 1 month, 3 months. |
| 1623958 | Background | Maepea O. Pressures in the anterior ciliary arteries, choroidal veins and choriocapillaris. Exp Eye Res. 1992 May;54(5):731-6. doi: 10.1016/0014-4835(92)90028-q. |
| 16151785 | Background | Wilhelm B, Ludtke H, Wilhelm H; BRAION Study Group. Efficacy and tolerability of 0.2% brimonidine tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION): a 3-month, double-masked, randomised, placebo-controlled trial. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):551-8. doi: 10.1007/s00417-005-0102-8. Epub 2005 Sep 8. |
| 7844872 | Background | Optic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy (NAION) is not effective and may be harmful. The Ischemic Optic Neuropathy Decompression Trial Research Group. JAMA. 1995 Feb 22;273(8):625-32. |
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |