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Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02540148
First Posted: September 3, 2015
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Eye Machine Canada Inc.
September 1, 2015
September 3, 2015
November 2, 2017
November 1, 2017
February 28, 2018   (Final data collection date for primary outcome measure)
The primary outcome will be the mean change in visual acuity at the six week visit of the study group versus the control group. [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT02540148 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
This randomized study will assess the effectiveness of externally applied micro current electrical stimulation on improving the visual acuity in subjects with vision loss from dry (non-neovascular) age-related macular degeneration (AMD) over a 6 week period.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age-Related (Dry) Macular Degeneration
  • Device: Nova Oculus™ Micro-current electrical stimulation
    Active treatment with transpalpebral micro-current electrical stimulation device, 3 sessions within 5 days of the 1st treatment and 1 session during week 2.
  • Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatment
    Non-active treatment with transpalpebral micro-current electrical stimulation device, 3 sessions within 5 days of the 1st treatment and 1 session during week 2.
  • Experimental: Active Treatment
    Subjects will undergo three treatment sessions to the enrolled eyes within 5 days of the 1st treatment, followed by a treatment session on one day during week 2 with the Nova Oculus™ transpalpebral micro-current electrical stimulation device.
    Intervention: Device: Nova Oculus™ Micro-current electrical stimulation
  • Sham Comparator: Non-active treatment
    Subjects will undergo three non-active treatment sessions (no micro-current will be administered by the Nova Oculus™ transpalpebral micro-current electrical stimulation device) to the enrolled eyes within 5 days of the 1st treatment, followed by another non-active treatment session on one day during week 2.
    Intervention: Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
April 30, 2018
February 28, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fifty years of age or older
  • Male or female
  • Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye
  • Confirmed diagnosis of dry (non-neovascular) AMD
  • Vision loss attributable to dry (non-neovascular) AMD

Exclusion Criteria:

  • Any retinal pathology other than dry AMD
  • Evidence or history of wet AMD
  • Previous intravitreal injection
  • Seizure disorders
  • Dense cataract
  • Eyelid pathology at the treatment sites
  • Any prior electrical micro-stimulation treatment to the eyes
  • Poor general health
  • Active cancer
  • Life expectancy less than 12 months
  • Non-ambulatory
  • Not considered suitable for participation for any other reason
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT02540148
NO001C
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
The Eye Machine Canada Inc.
The Eye Machine Canada Inc.
Not Provided
Principal Investigator: Michael Fielden, MD Independent
The Eye Machine Canada Inc.
October 2017

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