Microcurrent stimulation Therapy for Treatment of AMD
Research type
Research Study
Full title
Microcurrent stimulation therapy for dry age-related macular degeneration (i-SIGHT): a multicenter, randomized, double-masked, clinical device trial.
IRAS ID
284694
Contact name
Tim Jackson
Contact email
Sponsor organisation
i-Lumen Scientific Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 10 days
Research summary
Age-related macular degeneration (AMD) is a debilitating eye disease that affects more than 100 million people worldwide. AMD is a generative disease affecting the macula: the most sensitive part of the retina used for seeing details, and essential for clear central vision. As AMD progresses, the quality of the central vision deteriorates and reduces patient's ability to do everyday tasks such as reading, driving, recognising faces. AMD is classified as dry AMD in the earlier stages and then progresses to wet AMD. Currently, there is no cure for dry AMD. Treatment consists of close monitoring to ensure the condition is not progressing to wet AMD, and nutritional recommendations.
The aim of this study it to investigate the safety and efficacy of a new device called i-Lumen AMD therapy for the treatment of dry AMD. The device uses microcurrent stimulation therapy: it creates an alternating pulsed direct current which delivers an ionic charge to the retina through electrodes placed on the eyelids. The impulse therapy restores cellular metabolism and restarts the neural pathway.
The study is a multicenter (3 centers), randomised (half of the patients get the treatment and half of the patients get a sham treatment), double-masked (both the patients and the research personnel are masked as to what treatment patients receive) clinical trial. Recruitment will take place at 3 clinical sites in England.
Each participant will have i-Lumen AMD therapy, either active or sham, in the study eye over five consecutive days for the initial treatment period, followed by one day “maintenance” treatments at the one, two and five-month follow-up timepoints. Follow-up duration is 12-month.
Main expected potential benefits are an improvement in best-corrected visual acuity, and slower disease progression.
Research if funded by the manufacturer i-Lumen Scientific.REC name
South East Scotland REC 02
REC reference
20/SS/0099
Date of REC Opinion
3 Nov 2020
REC opinion
Further Information Favourable Opinion