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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-12

Study Completion Date

2025-06-15

Brief Summary

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

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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i-Lumen AMD Active

Active transpalpebral microcurrent stimulation therapy

Group Type EXPERIMENTAL

i-Lumen(TM) AMD

Intervention Type DEVICE

Transpalpebral microcrurrent stimulation

i-Lumen AMD Sham

Sham transpalpebral microcurrent stimulation therapy

Group Type SHAM_COMPARATOR

i-Lumen(TM) AMD Sham

Intervention Type DEVICE

Transpalpebral sham stimulation

Interventions

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i-Lumen(TM) AMD

Transpalpebral microcrurrent stimulation

Intervention Type DEVICE

i-Lumen(TM) AMD Sham

Transpalpebral sham stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥50 years.
* Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy
* Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye

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)
* Central chorioretinal atrophy in the study eye
* Glaucoma in the study eye

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No