Age-Related (Dry) Macular Degeneration
Conditions
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.
Interventions
DEVICENova 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.
DEVICENova 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.
Sponsors
The Eye Machine Canada Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Canada
Outcome results
None listed