Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 3, 2008
December 4, 2008
April 2008
April 2008   (final data collection date for primary outcome measure)
Visual acuity [ Time Frame: Baseline, Final ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00802698 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Transcorneal Stimulation in Cases of Central Retinal Artery Occlusion Using a New Waveform
Not Provided

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Central Retinal Artery Occlusion
  • 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
Experimental: Group 1
Interventions:
  • Device: Transcorneal electric stimulation
  • Device: Transcorneal stimulation
  • Device: transcorneal electric stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
Not Provided
April 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact: Miriam Jessica López-Miranda, MD 10841400 ext 1171 retinamex@yahoo.com
Contact: Miriam Jessica Lopez-Miranda, MD 10841400 ext 1172 jessicalop@hotmail.com
Mexico
 
NCT00802698
APEC-039
Not Provided
Asociación para evitar la ceguera en méxico, APEC
Asociación para Evitar la Ceguera en México
Not Provided
Principal Investigator: Miriam Jessica Lopez-Miranda, MD APEC
Asociación para Evitar la Ceguera en México
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP