Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT) (i-SIGHT)
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ClinicalTrials.gov Identifier: NCT05447650 |
Recruitment Status :
Recruiting
First Posted : July 7, 2022
Last Update Posted : September 2, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Age-Related Macular Degeneration Dry Age-related Macular Degeneration Nonexudative Age-related Macular Degeneration | Device: i-Lumen(TM) AMD Device: i-Lumen(TM) AMD Sham | Not Applicable |
The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.
Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial. |
Actual Study Start Date : | April 12, 2022 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | March 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: i-Lumen AMD Active
Active transpalpebral microcurrent stimulation therapy
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Device: i-Lumen(TM) AMD
Transpalpebral microcrurrent stimulation |
Sham Comparator: i-Lumen AMD Sham
Sham transpalpebral microcurrent stimulation therapy
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Device: i-Lumen(TM) AMD Sham
Transpalpebral sham stimulation |
- Adverse Device Effects [ Time Frame: Through study completion, Month 12 timepoint ]Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study
- Mean change best corrected distance visual acuity [ Time Frame: Through Month 12 timepoint ]Mean change from baseline of best corrected distance visual acuity (CDVA) letter score

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Age ≥50 years.
- Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD
- Best-corrected distance visual acuity 20/63 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye
Key Exclusion Criteria:
- History and/or evidence of exudative age-related macular degeneration in either eye
- History and/or evidence of diabetic retinopathy in either eye
- Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
- Geographic atrophy in the study eye
- Central chorioretinal atrophy in the study eye
- Glaucoma in the study eye

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05447650
Contact: Meredith Mundy | 408-440-7049 | clinical@i-lumen.com |
United States, Arizona | |
Associated Retina Consultants | Recruiting |
Phoenix, Arizona, United States, 85020 | |
Contact: Hannah Brookins 602-242-4928 hannah.brookins@doctrials.com | |
Contact: Gabrielle Santor 602-242-492 gabrielle.santor@doctrials.com | |
Principal Investigator: Benjamin Bakall, MD | |
United States, California | |
Bay Area Retina Associates | Recruiting |
Walnut Creek, California, United States, 94598 | |
Contact: Luis Monslave 925-945-6800 lmonsalve@bayarearetina.com | |
Principal Investigator: Caesar Luo, MD | |
United States, Pennsylvania | |
Cumberland Valley Retina Consultants | Recruiting |
Chambersburg, Pennsylvania, United States, 21740 | |
Contact: Katie Wintersteen 240-651-8161 KatieW@RetinaCare.net | |
Principal Investigator: Allen Hu |
Study Director: | Meredith Mundy | i-Lumen Scientific, Inc. |
Responsible Party: | i-Lumen Scientific, Inc. |
ClinicalTrials.gov Identifier: | NCT05447650 |
Other Study ID Numbers: |
ILS-AMD-201 |
First Posted: | July 7, 2022 Key Record Dates |
Last Update Posted: | September 2, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
AMD Dry AMD |
Macular Degeneration Geographic Atrophy Retinal Degeneration Retinal Diseases Eye Diseases |