There is one clinical trial.
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.
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 ---
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 weeks