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Inclusion criteria were documented dry AMD, best corrected visual acuity (BCVA) of 20/20 to 20/200 and older than 50 years of age. Excluded from the study were subjects with previous or active wet AMD, with a previous history of epilepsy, with cognitive impairment, other retinal disease, previous retinal surgery, significant media opacity or contraindications to dilation drops. The non-presence of neovascularization was ascertained prior to enrollment by examination with Ocular Coherence Tomography (OCT) and Intra-venous Fluorescein Angiography (IVFA) and confirmed by a retina specialist. All subjects were assessed for Visual Acuity with ETDRS charts at 4 meter distance (Precision Vision, USA) recorded in log MAR units, contrast sensitivity at 1.5 and 3 cycles per degree (Stereo Vision Optec 6500, USA) recorded as log contrast sensitivity and for fixation stability with the Nidek MP1 micro perimeter (Nidek Technologies, Padova, Italy). Accurate estimates of fixation stability could be obtained from raw data provided by the instrument by calculation of a Bi-Curve Ellipse Area (BCEA) 11. Calculations are based on the minor and major axes of an ellipse area covering fixational eye movements and takes into account two standard deviation measures of each recorded eye movement. The results are expressed in square degrees. Measurements took place prior to treatment, immediately following the treatment protocol (6weeks), 4, 6 and 12 months after. The intervention consisted of using LLLT in the yellow and red to near-IR range using low-energy delivery with the Warp10 (Quantum Devices) and the Gentlewaves (Light Bioscience) instruments. The instruments used are commercially available and have been approved for use in other conditions by the FDA and Health Canada. The FDA considers one of the devices a non -significant risk device for using on the eye. The other device is of even lower power. The treatment parameters followed for the Warp10 delivery system were 670nm +/- 15nm at 50-80 mW/cm2, 4-7.68 J/cm2, for 88 +/- 8 seconds. The treatment parameters followed for the Gentlewaves delivery system were 590nm +/- 8nm at 4mW, 790nm +/- 60nm at 0.6mW, for 35 seconds, pulsed at 2.5 Hz (250 milliseconds on, 150 milliseconds off) while delivering 0.1J/cm2/treatment. All subjects were treated with the two devices used sequentially at each treatment visit for a total of 18 treatments over a six-week period (3 times per week for 6 weeks). The primary outcome measures selected for analysis were visual acuity, contrast sensitivity and fixation stability estimates. Data analysis was based on descriptive statistics that include frequency distributions, a measure of central tendency (mean) and a measure of dispersion (standard deviation). A statistical comparison of means between populations was made by t-test and repeated measures analysis of variance (repeated measures ANOVA). Differences were considered to be statistically significant at p values of less than 0.05. The study was performed in adherence to the guidelines of the Declaration of Helsinki. The study protocol was approved by an independent Research Ethics Committee (IRB Services, Aurora, Canada). Informed consent was obtained from all participants.PDF Image | dry Age-related Macular Degeneration Photobiomodulation
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