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

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ClinicalTrials.gov Identifier: NCT02540148
Recruitment Status : Not yet recruiting
First Posted : September 3, 2015
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
The Eye Machine Canada Inc.

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)

Condition or disease Intervention/treatment Phase
Age-Related (Dry) Macular Degeneration Device: Nova Oculus™ Micro-current electrical stimulation Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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 ]


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

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

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


Contacts
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Contact: Justin Sather 403-919-8555 justinsather@gmail.com

Locations
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Canada, British Columbia
Dr. Kevin Parkinson Active, not recruiting
Coquitlam, British Columbia, Canada, V3K 3N9
Sponsors and Collaborators
The Eye Machine Canada Inc.
Investigators
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Principal Investigator: Kevin Parkinson, MD Independent

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Responsible Party: The Eye Machine Canada Inc.
ClinicalTrials.gov Identifier: NCT02540148     History of Changes
Other Study ID Numbers: NO001D
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases