Tests a microcurrent eye device for dry age-related macular degeneration
Tests an eyelid microcurrent device in older adults with dry macular degeneration.
Plain-language title generated from the registry record
Registry title: Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Key facts
- Where
- Remuera, New ZealandSee the site
Where in New Zealand
- Auckland Eye LimitedRemuera, New ZealandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- i-Lumen Scientific AUS PTY LTD
- Trial code
- NCT06662162
- Record updated
- 26 August 2026
- Original description
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.Read full original descriptionShow less
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.
Participants will:
* Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. * Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.
Inclusion: Presence of at least one large druse >125 microns in diameter due to AMD; BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200]).
Exclusion: Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening; Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker; Known severe allergy to fluorescein dye; History of seizure disorders, chronic migraines and/or cluster headaches; Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.); History of intravitreal injections for GA (e.g., Syfovre or Izervay); Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy; History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening; History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month from Screening; History of amblyopia; Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L); Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck); Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day); Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa); History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre; History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre; GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT; Visually significant cataracts and/or visually significant posterior capsular opacification.