Back to resultsTranspalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Primary Purpose
Age-Related (Dry) Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nova Oculus™ Micro-current electrical stimulation
Nova Oculus™ Micro-current electrical stimulation - Sham treatment
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related (Dry) Macular Degeneration
Eligibility 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
Sites / Locations
- Dr. Kevin Parkinson
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active Treatment
Non-active treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT02540148
First Posted
September 1, 2015
Last Updated
August 13, 2021
Sponsor
The Eye Machine Canada Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02540148
Brief Title
Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Official Title
Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Eye Machine Canada Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related (Dry) Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-active treatment
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Nova Oculus™ Micro-current electrical stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nova Oculus™ Micro-current electrical stimulation - Sham treatment
Intervention Description
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Parkinson, MD
Organizational Affiliation
Independent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Kevin Parkinson
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3N9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
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