Clinical Trials
iSight2 (iLumen)
Microcurrent stimulation therapy for intermediate to advanced nonexudative age-related macular degeneration (i-SIGHT2): a multicentre, randomised, sham-controlled, double-masked, clinical device trial.
Overview
This research is testing a new potential treatment for dry AMD called the i-Lumen AMD microcurrent electrical stimulation device. The i-Lumen AMD device, developed by i-Lumen Scientific, Inc., a USA based manufacturer, is a medical device for use in an “office” setting. The i-Lumen AMD is a microcurrent electrical stimulation (MCS) device, which means that it delivers a low level of electrical stimulation. The stimulation is delivered through an electrode placed on the closed upper eyelid. An additional electrode is placed at the back of the neck, and helps to direct the MCS current to the back of the eye to the retina and the macula (the central part of the retina responsible for detailed vision). MCS may help to improve the function of support cells within the retina called retinal pigment epithelium (RPE) that may not be functioning properly due to AMD.
The purpose of this research study is to assess the safety and effectiveness of the i-Lumen AMD device and see how ongoing treatments may improve vision and may slow the progression of dry stages of AMD in participants who meet the criteria for the study. In this study, some participants will receive the active (or “real”) study treatment, while others will receive a sham (or fake/inactive) study treatment, which is administered like the active study treatment, but has no medical effect.
If you are eligible, prior to the first treatment session, you will be randomly assigned to receive either active microcurrent study treatment or sham (inactive) study treatment. Randomly means that no one influences which group you are assigned to; it depends on chance and is done by a computer program. Twice as many participants will be randomised in the active group compared to the sham (inactive) group. This means that you will have a 66.6% (2 in 3) chance of receiving active microcurrent study treatment and a 33.3% (1 in 3) chance of receiving sham (inactive) study treatment.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator
Professor Robyn Guymer AM
This research is testing a new potential treatment for dry AMD called the i-Lumen AMD microcurrent electrical stimulation device. The i-Lumen AMD device, developed by i-Lumen Scientific, Inc., a USA based manufacturer, is a medical device for use in an “office” setting. The i-Lumen AMD is a microcurrent electrical stimulation (MCS) device, which means that it delivers a low level of electrical stimulation. The stimulation is delivered through an electrode placed on the closed upper eyelid. An additional electrode is placed at the back of the neck, and helps to direct the MCS current to the back of the eye to the retina and the macula (the central part of the retina responsible for detailed vision). MCS may help to improve the function of support cells within the retina called retinal pigment epithelium (RPE) that may not be functioning properly due to AMD.
The purpose of this research study is to assess the safety and effectiveness of the i-Lumen AMD device and see how ongoing treatments may improve vision and may slow the progression of dry stages of AMD in participants who meet the criteria for the study. In this study, some participants will receive the active (or “real”) study treatment, while others will receive a sham (or fake/inactive) study treatment, which is administered like the active study treatment, but has no medical effect.
If you are eligible, prior to the first treatment session, you will be randomly assigned to receive either active microcurrent study treatment or sham (inactive) study treatment. Randomly means that no one influences which group you are assigned to; it depends on chance and is done by a computer program. Twice as many participants will be randomised in the active group compared to the sham (inactive) group. This means that you will have a 66.6% (2 in 3) chance of receiving active microcurrent study treatment and a 33.3% (1 in 3) chance of receiving sham (inactive) study treatment.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator
Learn more
View this study at ClinicalTrials.gov
This database listing provides more detailed information about this study.