Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
Launched by THE EYE MACHINE CANADA INC. · Sep 1, 2015
Trial Information
Current as of August 11, 2025
Completed
Keywords
ClinConnect Summary
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-f...
Gender
ALL
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
About The Eye Machine Canada Inc.
Eye Machine Canada Inc. is a leading clinical trial sponsor dedicated to advancing ocular health through innovative research and development. Focused on the exploration and evaluation of cutting-edge ophthalmic technologies and treatments, the organization collaborates with healthcare professionals and research institutions to conduct rigorous clinical trials. With a commitment to improving patient outcomes and enhancing the understanding of eye diseases, Eye Machine Canada Inc. strives to contribute significantly to the field of ophthalmology, ensuring that new therapies meet the highest standards of safety and efficacy.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Coquitlam, British Columbia, Canada
Patients applied
Trial Officials
Kevin Parkinson, MD
Principal Investigator
Independent
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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