Overview of the Clinical Trial

The Nova Oculus III study “Transpalpebral Microcurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration” was conducted between 2018 and 2021 by Kevin Parkinson, MD of Coquitlam, British Columbia. Study results showed that the medical therapy provided by the Nova Oculus III device was safe and effective when properly administered by a trained eye care professional. It was a randomized, blinded, placebo-controlled study involving both male and female subjects 50-years-old and older with vision loss from dry AMD.

Study results showed an improvement in visual acuity by more than 8 letters as compared to the placebo group. Contrast sensitivity also showed a marked improvement in the treatment group. The study did not find any evidence of significant side effects or negative consequences. These findings are extremely significant considering that people with dry AMD always have worse vision over time; and supplements may slow the progression, but they don’t stop it or improve vision significantly.

The study’s principal investigator, Dr. Kevin Parkinson, stated: “as the primary investigator…I have witnessed and documented both the stark reality of…dry AMD…and for the first time in my 23-year practice history, a treatment that allows visual improvements in those suffering from it.” “But the true benefits of this treatment modality are not measured with an eye chart but in daily life.” “The reversal of some of the vision loss in the treated patients was seen by many as, quite frankly, ‘an unexpected miracle’.” “As a painless… device without any known side effects or drawbacks, I look forward to the day when I can offer it to my patients and spread the word of its efficacy to my colleagues and the Canadian public.”

Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation

Nova Oculus, formerly The Eye Machine, is pleased to share the results of a clinical study employing the Nova Oculus III microcurrent medical therapy device for the treatment of patients with the AMD disease through an article in the International Journal of Retina and Vitreous, published 18 June 2023.

The study, conducted by Kevin M. Parkinson, Eric C. Sayre, and Sheldon W. Tobe “demonstrated improved visual measures and is very encouraging as a potential treatment for dry AMD.” Based on this study and other supportive data, this treatment therapy that we developed was approved by Canada’s regulatory authority, Health Canada, for use in Canada last year in November.

Please see the full article here: https://journalretinavitreous.biomedcentral.com/counter/pdf/10.1186/s40942-023-00471-y.pdf

NOTE: We regret any potential confusion which may be caused by this article, which makes mention of our device, the Nova Oculus III, which was used in this clinical trial, as a MacuMira device. MacuMira was a contractor we used to arrange for the clinical study which is the subject of this article. In the article it mentions MacuMira as located in Palm Desert, California, while in reality Nova Oculus is headquartered here and MacuMira is located in Canada.

Source: BioMed Central Ltd

Timeline for Availability to Public

Nova Oculus is working very hard to bring this amazing treatment to the Canadian people. The lead investigator in the study that led to Health Canada’s approval calls it “miraculous!” Our goal is to have treatment sites by the end of 2023, if possible. Watch this website for more information.

Some Background on AMD

Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in adults over age 50. It is estimated that 2.5 million Canadians have AMD. Caucasians, especially those with lighter colored eyes, are at higher risk for developing AMD than other races. Women also develop AMD at an earlier age than men. This eye disease occurs when there are changes to the macula, a small portion of the retina that is located on the inside back layer of the eye. AMD is a loss of central vision that can occur in two forms: “dry” (atrophic) and “wet” (exudative). Most people with macular degeneration have a dry form. While there is not yet an approved, specific treatment for dry AMD, studies have shown a potential benefit from vitamin supplements, a Mediterranean diet, protection from the ultraviolet light of the sun and cessation of smoking. The less common wet form may respond to in-the-eye injections of anti-VEGF medications if detected and treated early.

Some of the known causes of AMD are heredity, UV light exposure, smoking, poor nutrition, and lack of exercise.

In its early stages, many people may not notice any signs or symptoms of AMD. As AMD progresses and worsens, it causes the gradual loss of the ability to see objects clearly (faces, road signs, reading materials, etc.). The shape of objects may appear to be distorted, wavy or crooked, and there is a loss of clear color vision. Eventually there can be a dark or empty area in the center of one’s vision.

Experts recommend that those with AMD increase antioxidant foods in the diet, wear sunglasses to protect the eyes from UV light, discontinue all use of tobacco products, exercise for cardiovascular health, control and monitor diabetes and hypertension, and take a supplement with lutein, zeaxanthin and mesozeaxanthin in its formula.