Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540148
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
The Eye Machine Canada Inc.

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE November 15, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment. [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Official Title  ICMJE Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Brief Summary Assess the effectiveness of externally applied micro current electrical stimulation on improving the ETDRS visual acuity in subjects with vision loss from dry age-related macular degeneration (AMD)
Detailed Description Micro-current electrical stimulation will be used to treat /each eye in a group of subjects with dry AMD. 60 subjects will be randomly divided into two groups. A ratio of 1:3 will be maintained between control and the experimental groups. In the treatment group, subjects will undergo a treatment session to the enrolled eyes daily for three days during week 1, followed by a single treatment session during weeks 2, 14 and 26 with the Nova Oculus device. A second group of subjects will act as the control group. This group will undergo sham treatment at the same treatment intervals with a non-functional Nova Oculus device. ETDRS visual acuity will be performed on all subjects at enrollment prior to each treatment and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the ETDRS visual acuity of subjects with dry AMD will be determined.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Age-Related (Dry) Macular Degeneration
Intervention  ICMJE
  • 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. 1 session during weeks 2, 14 and 26.
  • Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatment
    Non-active treatment with transpalpebral micro-current electrical stimulation SHAM device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26.
Study Arms  ICMJE
  • Experimental: Active Treatment
    Patients will be fully consented before the start of the study. In the treatment group, subjects will undergo a treatment session to the enrolled eyes for three days during Week 1, followed by a single treatment session during Weeks 2, 14 and 26 with the Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined.e.
    Intervention: Device: Nova Oculus™ Micro-current electrical stimulation
  • Sham Comparator: Non-active treatment
    A second group of subjects will act as the control group. This group will undergo sham treatment to the enrolled eyes at the same intervals as the treatment group (Weeks 2, 14 and 26), but with a nonfunctional Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined.
    Intervention: Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
30
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fifty years of age or older
  • Male or female
  • Best-corrected vision 20/50 to 20/200 for each enrolled eye
  • Confirmed diagnosis of dry AMD
  • Vision loss attributable to dry AMD
  • Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent

Exclusion Criteria:

  • Any visually significant retinal pathology other than dry AMD
  • Previous intravitreal injection
  • Seizure disorders
  • Previous vitreo-retinal surgery. (ERM, PPV, RD etc)
  • Dense cataract
  • Eyelid pathology at the treatment sites
  • Glaucoma patients with a visual field mean defect of greater than 10dB on Humphrey visual field testing
  • Glasses are up to date (prescription <1 year old)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Justin Sather 403-919-8555 justinsather@gmail.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02540148
Other Study ID Numbers  ICMJE NO001D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Eye Machine Canada Inc.
Study Sponsor  ICMJE The Eye Machine Canada Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin Parkinson, MD Independent
PRS Account The Eye Machine Canada Inc.
Verification Date February 2020

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