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Device

Microcurrent Stimulation for Age-Related Macular Degeneration (i-SIGHT Trial)

N/A
Recruiting
Research Sponsored by i-Lumen Scientific, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
Age ≥50 years.
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

i-SIGHT Trial Summary

This trial will test a new eye treatment for people with a specific type of macular degeneration.

Who is the study for?
This trial is for people over 50 with a condition called dry age-related macular degeneration (AMD), specifically at an intermediate stage. Participants must have certain levels of vision in both eyes and cannot be current or heavy past smokers, nor can they have other eye conditions like wet AMD, diabetic retinopathy, or glaucoma.Check my eligibility
What is being tested?
The i-SIGHT trial is testing the safety and effectiveness of a treatment called transpalpebral microcurrent stimulation therapy using a device named i-Lumen(TM) AMD. Some participants will receive the actual therapy while others get a sham (fake) treatment to compare results.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort around the eye area due to the device application or unexpected reactions from electrical stimulation.

i-SIGHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I'm sorry, but I cannot provide a simplified explanation for the criterion "Key" as it is incomplete and lacks context. Please provide more information.
Select...
I am 50 years old or older.
Select...
I have intermediate age-related macular degeneration.
Select...
I am 50 years old or older.
Select...
I have intermediate age-related macular degeneration.

i-SIGHT Trial Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Device Effects
Other outcome measures
Mean change best corrected distance visual acuity

i-SIGHT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: i-Lumen AMD ActiveExperimental Treatment1 Intervention
Active transpalpebral microcurrent stimulation therapy
Group II: i-Lumen AMD ShamPlacebo Group1 Intervention
Sham transpalpebral microcurrent stimulation therapy

Find a Location

Who is running the clinical trial?

i-Lumen Scientific, Inc.Lead Sponsor
2 Previous Clinical Trials
404 Total Patients Enrolled
Meredith MundyStudy Directori-Lumen Scientific, Inc.

Media Library

i-Lumen(TM) AMD (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05447650 — N/A
Age-Related Macular Degeneration Research Study Groups: i-Lumen AMD Active, i-Lumen AMD Sham
Age-Related Macular Degeneration Clinical Trial 2023: i-Lumen(TM) AMD Highlights & Side Effects. Trial Name: NCT05447650 — N/A
i-Lumen(TM) AMD (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05447650 — N/A
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT05447650 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial currently have any openings for participants?

"Affirmative, information on clinicaltrials.gov reveals that this trial is actively enrolling participants. Starting 4/12/2022 and most recently updated 9/1/2022, the study requires 60 subjects to be recruited across 3 different locations."

Answered by AI

How many people have signed up to take part in this medical investigation?

"To complete the trial, 60 participants with suitable eligibility criteria must partake from different locations. These include Associated Retina Consultants in Phoenix and Cumberland Valley Retina Consultants in Chambersburg."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
California
Other
Indiana
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
Bay Area Retina Associates
University Retina and Macula Associates, PC
Other
Erie Retina Research, LLC

What questions have other patients asked about this trial?

How long does screening take? How many trips are required? Are any medications or eye drops or shots involved?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Can't lose any more sight. My doctor recommended I see if any trial would benefit my situation.
PatientReceived no prior treatments
I have tried Avastin and Eyelia. I would like to improve may vision. I was on Facebook and saw this. The doctor said I have dry eyes and recommended refresh. Also said I have pre-macular degeneration.
PatientReceived 2+ prior treatments
My doctor recommended I try to find a trial for AMD to see if anything would help my vision. I like the idea that this is a device trial as opposed to medication or shots.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Erie Retina Research, LLC: < 24 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
2022. "Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05447650.
All > Age Related Macular Degeneration > Macular Degeneration
~20 spots leftby Apr 2025
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