NCT05447650

Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)

Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: i-Lumen Scientific, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).

Detailed description

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.

Conditions

• Age-Related Macular Degeneration
• Dry Age-related Macular Degeneration
• Nonexudative Age-related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	i-Lumen(TM) AMD	Transpalpebral microcrurrent stimulation
DEVICE	i-Lumen(TM) AMD Sham	Transpalpebral sham stimulation

Timeline

• Start date: 2022-04-12
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2022-07-07
• Last updated: 2025-06-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study