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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.
  Purpose
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.

Condition Intervention
Age-Related (Dry) Macular Degeneration Device: Nova Oculus™ Micro-current electrical stimulation Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by The Eye Machine Canada Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Anticipated Study Start Date: November 1, 2017
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540148


Locations
Canada, Alberta
Dr. Michael Fielden
Calgary, Alberta, Canada
Sponsors and Collaborators
The Eye Machine Canada Inc.
Investigators
Principal Investigator: Michael Fielden, MD Independent
  More Information

Responsible Party: The Eye Machine Canada Inc.
ClinicalTrials.gov Identifier: NCT02540148     History of Changes
Other Study ID Numbers: NO001C
First Submitted: September 1, 2015
First Posted: September 3, 2015
Last Update Posted: November 2, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases