Clinical trial NCT02540148: 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
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related (Dry) Macular Degeneration
Lead sponsor: The Eye Machine Canada Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment.
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coquitlam
country: Canada
facility: Dr. Kevin Parkinson
state: British Columbia
Study officials:
affiliation: Independent
name: Kevin Parkinson, MD
role: PRINCIPAL_INVESTIGATOR
References: