The Effect of Transcorneal Stimulation in Cases of Central Retinal Artery Occlusion Using a New Waveform
Primary Purpose
Central Retinal Artery Occlusion
Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Transcorneal electric stimulation
Transcorneal stimulation
transcorneal electric stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Central Retinal Artery Occlusion focused on measuring Biphasic waveform, Central retinal artery occlusion, To describe the effect of Transcorneal Electrical Stimulation (TES) with a non conventional biphasic bipolar waveform, in central retinal artery occlusion
Eligibility Criteria
Inclusion Criteria:
- central retinal Artery occlusion
- no retinal diseases associated
- visual acuity in other eye better than 20/200
Exclusion Criteria:
- Branch retinal artery occlusion
Sites / Locations
- APECRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group 1
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT00802698
First Posted
December 3, 2008
Last Updated
December 4, 2008
Sponsor
Asociación para Evitar la Ceguera en México
1. Study Identification
Unique Protocol Identification Number
NCT00802698
Brief Title
The Effect of Transcorneal Stimulation in Cases of Central Retinal Artery Occlusion Using a New Waveform
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asociación para Evitar la Ceguera en México
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to describe the effect of transcorneal electrical stimulation (TES) with a non conventional biphasic bipolar waveform in central retinal artery occlusion
Detailed Description
Patients with acute central retinal artery occlusion (CRAO) generally present with a history of painless visual loss that occurred over several seconds. In some instances amaurosis fugax is also present. At the time of initial examination, visual acuity in 90% of patients with CRAO can vary from counting fingers to light perception. Acute CRAO is considered an emergency situation, and therapy must be started as soon as possible. There are different reports where different treatments were proved for the acute phase for example: ocular massage, anterior chamber paracentesis, intravenous mannitol, acetazolamide, hyperbaric oxygenation, microcatheter urokinase infusion, and carbogen 1,2,3. Electrophysiological occlusion of the ophthalmic artery, central retinal artery occlusion, or central retinal vein has a profound impact on the ERG. ERG can provide an objective assessment of severity if occlusion occurs, the b wave is eliminated and a reduction in the "a" wave can be observed.
In addition, a traumatic optic neuropathy, together with retinal ganglion cell death, can induce a loss of vision which progresses rapidly within several hours l. It is known that the visual prognosis following treatment of acute central retinal artery occlusion is not as good as we would like 2; the patient must go to any emergency department to be treated immediately3, in order to preserve maximal visual function. It has been prove that the retinal function recovers after an ischemic event lasting up to 97 minutes, 4 and irreparable damage may occur after 105 minutes. This is why this study intervene during the chronic phase between 4 hrs and 14 days; where demonstrable clinical improvements in the magnitude of retinal damage where seen5, 6, 7 However recently research reports have shown that, electrical stimulation can rescue injured retinal ganglion cells from death cells and can preserve visual function after an optic nerve crush. 8 There is no ideal treatment in the chronic phase of the CRAO. That is the reason why most recent papers suggest different treatment approaches in the chronic phase of this pathology. One of these treatments that were described is the application of electrical stimulation on the patient's cornea who present with CRAO. It has been reported in the literature that transcorneal, retinal 9,10 or cerebral visual cortex 11 electrical stimulation (ES) results in evoked visual sensations (phosphenes),6,9,10,12 however, this intervention requires surgical electrode implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Artery Occlusion
Keywords
Biphasic waveform, Central retinal artery occlusion, To describe the effect of Transcorneal Electrical Stimulation (TES) with a non conventional biphasic bipolar waveform, in central retinal artery occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcorneal electric stimulation
Other Intervention Name(s)
TES
Intervention Description
central artery occlusion
Intervention Type
Device
Intervention Name(s)
Transcorneal stimulation
Other Intervention Name(s)
TES
Intervention Description
new waveform
Intervention Type
Device
Intervention Name(s)
transcorneal electric stimulation
Other Intervention Name(s)
TES
Intervention Description
Novel waveform central artery occlusion
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
Baseline, Final
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
central retinal Artery occlusion
no retinal diseases associated
visual acuity in other eye better than 20/200
Exclusion Criteria:
Branch retinal artery occlusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Jessica López-Miranda, MD
Phone
10841400
Ext
1171
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Jessica Lopez-Miranda, MD
Phone
10841400
Ext
1172
Email
jessicalop@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Jessica Lopez-Miranda, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
APEC
City
Mexico
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Jessica Lopez-Miranda, MD
Phone
10841400
Ext
1171
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name & Degree
Daniel Robles-Camarillo, MSc
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz -Mercado, MD
First Name & Middle Initial & Last Name & Degree
Luis Niño-de-Rivera y Oyarzabal, PhD
First Name & Middle Initial & Last Name & Degree
Gerardo García-Aguirre, MD
First Name & Middle Initial & Last Name & Degree
Virgilio Morales-Cantón, MD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Transcorneal Stimulation in Cases of Central Retinal Artery Occlusion Using a New Waveform
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