Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

Overseen by Kevin Parkinson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Eye Machine Canada Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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)

Research Team

Kevin Parkinson, MD

Principal Investigator

Independent

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

Treatment Details

Interventions

• Nova Oculus™ Micro-current electrical stimulation (Micro-current electrical stimulation)

Participant Groups

Group I: Active Treatment Experimental Treatment 1 Intervention

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.

Group II: Non-active treatment Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

The Eye Machine Canada Inc.

Lead Sponsor

Trials

1

Recruited

60+