Author: Larry Perich (United States)
Co-authors: Dan Montzka, Marion Munk, Stephanie Tedford, Cindy Croissant, Rene Ruckert, Clark Tedford
Purpose
Electroretinography is a quantitative and functional indicator of visual function and is an important tool for the diagnosis and management of retinal function in ocular disease. Dry age-related macular degeneration (AMD) demonstrates underlying mitochondrial dysfunction. Photobiomodulation (PBM) represents a light-based treatment modality that uses wavelengths in the 500-1000 nm range that activate components of the mitochondrial electron chain inducing positive changes in cellular bioenergy outputs. The Valeda multiwavelength light delivery device, and the Diopsys NOVA ERG device were used to investigate the effects on multiple parameters of visual function in the ELECTROLIGHT dry AMD study.
Setting/Venue
The study was conducted at a single center (Perich Eye Center) in New Richey, Florida, USA.
Methods
A total of 23 eyes from 15 subjects with intermediate Dry AMD were enrolled into the prospective clinical study and treated with one series of PBM treatment using the Valeda (3x per week for 3 weeks) and followed for 6 months. PBM therapy consists of low-level light exposure with 590, 660 and 850 nm wavelengths. Subjects were assessed for clinical and safety outcomes (i.e., visual acuity, contrast sensitivity, color vision, amsler grid test, perimetry, and ERG). Independent OCT outcomes at 3- and 6-months post-treatment were analyzed by an independent imaging center.
Results
Subjects showed approximately 12.6 ± 1.25 letter improvement in BCVA at month 1 and 12.3 ± 0.96 letter improvement at month 3 compared to BL scores. Mars Contrast Sensitivity (CS) showed improvement from BL to month 1 at 40 cm (0.165 log + 0.25), 80 cm (0.134 log + 0.20) and 120 cm (0.22 log + 0.37). Mars CS also showed improvement from BL to month 3 at 40 cm (0.183 log + 0.02), 80 cm (0.167 log + 0.02) and 120 cm (0.25 log + 0.03). A positive correlation between multi-luminance ERG and BCVA was seen and strong positive correlations between multi-luminance ERG and fixed luminance (R = 0.852) and Chromatic ERG outcomes (R = 0.710). Reductions in drusen were seen in select patients. Multi-luminance ERG Magnitude AUC improved by 14.4% from baseline to the fourth test after completion of the month 1 treatment, and this difference was determined to be significant (p = 0.001).
Conlusions
Valeda provided statistically significant improvements in BCVA, CS and multi-luminance ERG function from baseline at the month 1 time point following 9 PBM treatments with a sustained effect observed at months 1 and 3 in BCVA and CS. ERG increases in retinal function were seen after as few as 3 PBM treatments and improved over the course of 9 PBM treatments. PBM therapy represents a novel approach to treat patients with dry AMD and ERG may be an early biomarker to monitor improvement in retinal function following Valeda treatments. Diopsys multi-luminance ERG may be used as an early and sensitive measure of visual dysfunction in dry AMD patients.
Financial Disclosure
Diopsys, LumiThera - PI for sponsor funded study
Comments
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