The Effect of Transcorneal Stimulation in Cases of Central Retinal Artery Occlusion Using a New Waveform

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00802698
First received: December 3, 2008
Last updated: December 4, 2008
Last verified: December 2008
  Purpose

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


Condition Intervention Phase
Central Retinal Artery Occlusion
Device: Transcorneal electric stimulation
Device: Transcorneal stimulation
Device: transcorneal electric stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: Baseline, Final ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: April 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Device: Transcorneal electric stimulation
central artery occlusion
Other Name: TES
Device: Transcorneal stimulation
new waveform
Other Name: TES
Device: transcorneal electric stimulation
Novel waveform central artery occlusion
Other Name: TES

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802698

Contacts
Contact: Miriam Jessica López-Miranda, MD 10841400 ext 1171 retinamex@yahoo.com
Contact: Miriam Jessica Lopez-Miranda, MD 10841400 ext 1172 jessicalop@hotmail.com

Locations
Mexico
APEC Recruiting
Mexico, Mexico, 04030
Contact: Miriam Jessica Lopez-Miranda, MD    10841400 ext 1171    retinamex@yahoo.com   
Sub-Investigator: Daniel Robles-Camarillo, MSc         
Sub-Investigator: Hugo Quiroz -Mercado, MD         
Sub-Investigator: Luis Niño-de-Rivera y Oyarzabal, PhD         
Sub-Investigator: Gerardo García-Aguirre, MD         
Sub-Investigator: Virgilio Morales-Cantón, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Miriam Jessica Lopez-Miranda, MD APEC
  More Information

No publications provided

Responsible Party: Asociación para evitar la ceguera en méxico, APEC
ClinicalTrials.gov Identifier: NCT00802698     History of Changes
Other Study ID Numbers: APEC-039
Study First Received: December 3, 2008
Last Updated: December 4, 2008
Health Authority: Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:
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

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Retinal Artery Occlusion
Cardiovascular Diseases
Eye Diseases
Retinal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014