Microcurrent Stimulation Therapy for Age-Related Macular Degeneration
(i-SIGHT2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test the safety and effectiveness of a new treatment using the i-Lumen AMD device for individuals with nonexudative age-related macular degeneration (AMD). It involves microcurrent therapy, a gentle electrical stimulation applied to the eye area. Participants will be divided into two groups: one will receive the actual therapy, while the other will receive a placebo with no active treatment. This study may suit those with nonexudative AMD and vision challenges typically associated with this condition, provided they do not have electrical implants or severe eye conditions like uncontrolled diabetes or glaucoma. As an unphased trial, it offers an opportunity to explore innovative treatments for nonexudative AMD.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, certain conditions and treatments, like glaucoma requiring multiple medications or recent photobiomodulation therapy, may affect eligibility.
What prior data suggests that the i-Lumen AMD device is safe for patients with age-related macular degeneration?
Research has shown that the i-Lumen AMD device, used for microcurrent stimulation therapy, has undergone safety testing in people with age-related macular degeneration (AMD). These studies indicate that the treatment is generally well-tolerated, with most participants not experiencing serious side effects.
Some individuals have reported mild discomfort, such as slight tingling or warmth at the electrode sites. These sensations are usually temporary and do not cause long-term issues.
Overall, previous tests suggest the treatment is safe. However, discussing any concerns with a healthcare provider before joining a clinical trial is always important.12345Why are researchers excited about this trial?
Unlike the standard treatments for age-related macular degeneration, which often include injections or laser therapy, i-Lumen AMD offers a non-invasive approach through microcurrent stimulation therapy. This therapy uses gentle electrical currents applied through the eyelids to potentially improve retinal function. Researchers are excited about i-Lumen AMD because it targets cellular processes in the eye without the need for surgery or injections, offering a potentially safer and more comfortable option for patients.
What evidence suggests that the i-Lumen AMD device is effective for age-related macular degeneration?
Research has shown that microcurrent stimulation therapy, such as the i-Lumen AMD device, may help treat dry age-related macular degeneration (AMD). In this trial, participants will receive either active i-Lumen AMD therapy or a sham therapy. Studies suggest that this therapy could improve vision or slow the disease's progression by using tiny electrical currents to stimulate the retina, the part of the eye that detects light. This stimulation is believed to enhance the function of the retinal pigment epithelium, which is crucial for eye health. Early findings indicate that microcurrent therapy might delay degeneration in both dry and wet forms of macular degeneration. While more research is needed, these initial results offer hope for people with this condition.12356
Who Is on the Research Team?
Meredith Mundy
Principal Investigator
i-Lumen Scientific, Inc.
Are You a Good Fit for This Trial?
This trial is for people with intermediate to advanced dry (nonexudative) age-related macular degeneration who have at least one large deposit in the eye and vision between 20/40 and 20/200. Other major eye conditions may exclude participation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Loading Regimen
Participants undergo an initial loading regimen with the i-Lumen AMD device
Maintenance Treatment
Participants receive 7 maintenance treatments over the course of 11 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- i-Lumen AMD
Trial Overview
The study tests the safety and effectiveness of the i-Lumen AMD device, which uses gentle electrical stimulation through the eyelid, given over several sessions across about a year. Participants are monitored monthly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Active transpalpebral microcurrent therapy
Sham transpalpebral microcurrent therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
i-Lumen Scientific AUS PTY LTD
Lead Sponsor
i-Lumen Scientific, Inc.
Industry Sponsor
Citations
Study Details | NCT06662162 | Microcurrent Stimulation ...
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in ...
Microcurrent Stimulation Therapy for Nonexudative Age- ...
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration ...
3.
glance.eyesoneyecare.com
glance.eyesoneyecare.com/stories/2026-04-08/i-lumen-scientific-earns-fda-ide-clearance-for-dry-amd-trial/i-Lumen Scientific earns FDA IDE clearance for dry AMD trial
The i-Lumen AMD System carries out this stimulation externally—and without implants—via electrodes placed on a closed eyelid and back of the ...
iSight2 (iLumen)
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 ...
Microcurrent stimulation in the treatment of dry and wet ... - PMC
The changes observed indicate the potential efficacy of microcurrent to delay degeneration and possibly improve age-related macular degeneration, both wet and ...
Microcurrent stimulation Therapy for Treatment of AMD
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.
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