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The i-Lumen AMD system is a non-invasive medical device that delivers low-level microcurrent electrical stimulation through an electrode placed on the closed eyelid.
Eligible participants are randomly assigned to active or sham (inactive) therapy; two out of every three enrolled will receive the active therapy. Participants will complete a five-day treatment regimen (active or sham therapy), followed by 13 scheduled maintenance treatment days over a 24-month period.
The purpose of this research study is to assess the safety and effectiveness of the i‑Lumen AMD system and to determine how ongoing treatments may improve visual acuity and slow the progression of dry stages of AMD in people aged 60 years and older.
There is no guarantee or promise that participants will receive any benefits from this research.
It is important to discuss both the benefits and risks of participating with a study doctor.
Key inclusion criteria for study participation are listed below. Contact a participating research site to discuss whether you may meet the eligibility criteria.
* Your optometrist can tell you what your BCVA was at your last visit.
Participants will take part in a series of clinic visits over a 24-month period, including treatment sessions, follow-up assessments, and scheduled maintenance visits.
Below is an overview of what to expect at each stage of the study.
Purpose: Determine whether clinically eligible to participate in the trial.
What to expect: You will be asked about your medical history and undergo evaluations to assess your eye health and vision. This includes dilation of your eyes, imaging, and an exam by the study doctor.
Purpose: Confirm eligibility and establish baseline measurements.
What to expect: You will complete questionnaires and additional vision tests. The study team will confirm whether you continue to meet eligibility criteria and can be enrolled. If eligible, you will complete additional assessments, which will be used to measure any changes in your vision over the course of the study.
Purpose: Administration of the therapy over five days.
What to expect: Participants will be randomly assigned to receive either active therapy or sham (inactive) therapy. Two out of three participants will receive the active therapy. The i‑Lumen AMD Therapy is administered in five consecutive days (Monday through Friday), with two sessions per day. During each session, an electrode is placed on the closed eyelid(s), and another electrode is placed at the back of the neck. The entire session will be approximately 30 minutes if one eye is receiving therapy, and 40 minutes if both eyes are receiving therapy. There will be at least a 30-minute break between sessions. You will be asked questions after each session, and at the end of each day you will undergo assessments, including an eye exam to monitor for any side effects.
Purpose: Monitor changes to your eye health and vision over time.
What to expect: You will return to the clinic two weeks after the five-day treatment, and then every month for 24 months. At each visit, you will be asked about changes in your health or medications, complete questionnaires, and have your vision tested. Most visits will include imaging, and additional tests will be performed approximately every three months.
Purpose: Maintain and supplement the initial treatment.
What to expect: At scheduled visits throughout the study (months 1, 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23) participants will complete a maintenance therapy session following their assessments. Each maintenance session is one day, with two sessions and a 30-minute break in between. Maintenance therapy may take place on the same day as the assessment visit or on a separate day. After the second session, eyes will be dilated, imaging will be collected, and an eye exam will be conducted.
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