The study will explore the impact of photobiomodulation (PBM), pulsating at frequencies of red (660nm) and near-infrared (810nm)(NIR), concurrent with a ketogenic dietary protocol (serum ketones @ .5 - 2.0 mmol/L) to mediate vascular features of diabetic retinopathy (DR), diabetic macular edema (DME), age-related macular degeneration (AMD), mid-peripheral drusens, visual acuity and retinal disorders. Red and near-infrared light via light-emitting diode (LED) treatment promotes retinal healing and improves visual acuity by augmenting cellular energy metabolism, enhancing mitochondrial function, increasing cytochrome C oxidase activity, stimulating antioxidant protective pathways and promoting cell survival. LED therapy directly benefits neurons in the retina, the lateral geniculate nucleus and the visual cortex; likewise, a ketogenic dietary protocol shows metabolic and neuro-modulatory benefits within the CNS, most notably as treatment for refractory epilepsy. Photobiomodulation has been approved as a non-significant risk (NSR) modality for the treatment of eye disorders.
Name: Photobiomodulation
Name: Ketogenic diet
Description: Improvement in number and severity of hemorrhages and hard and soft exudates as measured by the Daytona Plus (Panoramic Ophthalmoscope P200T)
Measure: Diabetic Retinopathy (DR) pathology Time: 36 weeksDescription: Lower incidence of macular edema as measured by Optos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems
Measure: Diabetic Macular Edema (DME) pathology Time: 36 weeksDescription: Reduction in size and number of drusen in early and intermediate stages of Dry AMD pathology as measured byOptos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems
Measure: Dry Age-related Macular Degeneration (AMD) pathology Time: 36 weeksDescription: Reduction in size and/or density of drusen as measured by the Optos Daytona Plus (Panoramic Ophthalmoscope P200T)
Measure: Hard Drusen in the Mid-periphery pathology Time: 36 weeksDescription: Assessment of changes in HgA1c (Hemoglobin A1c) over time. Ranges: <5.7%
Measure: HgA1c Time: 36 weeksDescription: Assessment of changes in fasting insulin over time. Ranges: < 2.6-11.1 mU/L
Measure: Fasting Insulin Time: 36 weeksDescription: Assessment of changes in fasting glucose over time. Ranges 74-100 mg/dL
Measure: Fasting Glucose Time: 36 weeksDescription: Assessment of changes in HOMA-IR over time. Ranges <1.0
Measure: HOMA-IR Time: 36 weeksDescription: Assessment of changes in triglycerides/HDL ratio over time. Ranges <2.0
Measure: Triglycerides/HDL ratio Time: 36 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
Improvement in number and severity of hemorrhages and hard and soft exudates as measured by the Daytona Plus (Panoramic Ophthalmoscope P200T). --- P200T ---
Lower incidence of macular edema as measured by Optos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems. --- P200T ---
Reduction in size and number of drusen in early and intermediate stages of Dry AMD pathology as measured byOptos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems. --- P200T ---
Reduction in size and/or density of drusen as measured by the Optos Daytona Plus (Panoramic Ophthalmoscope P200T). --- P200T ---