BioCurrent Electrical Stimulation for the Treatment of Dry ARMD
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2016 |
End Date: | December 2016 |
Contact: | Colleen Titman |
Email: | telephonescreener@outlook.com |
Phone: | 509-244-6502 |
BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
This study evaluates the treatment of Dry Macular Degeneration and the resulting change in
vision with a very, very low current that is similar to what occurs in the body naturally.
In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham
(no treatment). After the treatment period of one week, those not treated will be treated.
In Phase 2, all participants will be treated.
vision with a very, very low current that is similar to what occurs in the body naturally.
In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham
(no treatment). After the treatment period of one week, those not treated will be treated.
In Phase 2, all participants will be treated.
The study will assess the effectiveness of transpalpebral micro-current electrical
stimulation on improving the visual acuity in subjects with vision loss from Dry Macular
Degeneration. The BioCurrent electrical stimulation will be applied by a device with the
intended use of treating Dry Macular Degeneration (Nova Oculus ; The Eye Machine, Indian
Wells, CA, U.S.A.). The device delivers a micro-current, an electrical current in the one
millionth of an ampere range, to the retina in frequencies changing in a pre-defined pattern
from 5Hz to 80Hz during each spot (40 sec). The device also incorporates a voltage limiter
(a maximum of 245 micro A is possible) and a current level indicator. 200 micro A will be
used. Very low electrical micro-current is delivered to the subject through the goggle
probe.
stimulation on improving the visual acuity in subjects with vision loss from Dry Macular
Degeneration. The BioCurrent electrical stimulation will be applied by a device with the
intended use of treating Dry Macular Degeneration (Nova Oculus ; The Eye Machine, Indian
Wells, CA, U.S.A.). The device delivers a micro-current, an electrical current in the one
millionth of an ampere range, to the retina in frequencies changing in a pre-defined pattern
from 5Hz to 80Hz during each spot (40 sec). The device also incorporates a voltage limiter
(a maximum of 245 micro A is possible) and a current level indicator. 200 micro A will be
used. Very low electrical micro-current is delivered to the subject through the goggle
probe.
Inclusion Criteria:
- 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 MD
- Vision loss attributable to Dry MD
- 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 retinal pathology other than Dry MD
- Evidence or history of wet MD
- 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
We found this trial at
1
site
DuBois, Pennsylvania 15801
Principal Investigator: Wendy Strouse Watt, Optometrist
Phone: 814-371-7231
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