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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)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | 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. |
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| Non-active treatment | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nova Oculus™ Micro-current electrical stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment. | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Parkinson, MD | Independent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kevin Parkinson | Coquitlam | British Columbia | V3K 3N9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37331928 | Derived | Parkinson KM, Sayre EC, Tobe SW. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation. Int J Retina Vitreous. 2023 Jun 18;9(1):36. doi: 10.1186/s40942-023-00471-y. |
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| Nova Oculus™ Micro-current electrical stimulation - Sham treatment | Device | 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. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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