Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT00802698 |
Other study ID # |
APEC-039 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 2008 |
Est. completion date |
April 2008 |
Study information
Verified date |
May 2024 |
Source |
Asociación para Evitar la Ceguera en México |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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.