Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration (ELECTROLIGHT)
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|ClinicalTrials.gov Identifier: NCT04522999|
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : September 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Device: Photobiomodulation||Not Applicable|
This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment.
Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks.
The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration|
|Actual Study Start Date :||August 20, 2020|
|Actual Primary Completion Date :||August 13, 2021|
|Actual Study Completion Date :||August 13, 2021|
Valeda™ Light Delivery System
The Valeda™ Light Delivery System
- ERG function [ Time Frame: 3 months ]ERG assessments (Multifocal ERG (mfERG), Photopic Negative Response (PhNR), Multi-luminance Flicker ERG (ML-FERG) and Fixed-luminance Flicker ERG (FL-FERG)) will provide an output of retinal function.
- ETDRS Visual Acuity [ Time Frame: 3 months ]Measurement of Visual function.
- Mars Contrast Sensitivity [ Time Frame: 3 months ]Measurement of Visual function.
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): NCT04522999
|United States, Florida|
|Perich Eye Center|
|New Port Richey, Florida, United States, 34655|