Subjects in the experimental group will receive clinically prescribed meal plans designed to facilitate prolonged benign dietary ketosis (BDK) purposed at glucose regulation, improved insulin sensitivity and restored metabolic flexibility. Photobiomodulation therapy, via Joovv red light/infrared LED device, will be administered three times per week, 20 minutes per session.

Subjects in the control group will follow current dietary protocol (Standard American Diet- SAD). Photobiomodulation therapy,via Joovv red light/infrared LED device, will be administered three times per week, 20 minutes per session.

Diabetic Retinopathy (DR)

Age-related Macular Degeneration (AMD)

Mid-peripheral Drusen Formation

Diabetic Macular Edema (DME)

Photobiomodulation therapy, via Joovv red light/infrared LED device, three days/week, 20 minutes per session for experimental and control groups.

Photobiomodulation

Experimental group will follow a clinically prescribed ketogenic diet.

Ketogenic diet

Yankee Eye Clinic

Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention

Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders (Diabetic Retinopathy, Dry AMD, Hard Drusen Formation) for Alzheimer's Disease Prevention

Improvement in number and severity of hemorrhages and hard and soft exudates as measured by the Daytona Plus (Panoramic Ophthalmoscope 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

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

Reduction in size and/or density of drusen as measured by the Optos Daytona Plus (Panoramic Ophthalmoscope P200T)

Assessment of changes in HgA1c (Hemoglobin A1c) over time. Ranges: <5.7%

Assessment of changes in fasting insulin over time. Ranges: < 2.6-11.1 mU/L

Assessment of changes in fasting glucose over time. Ranges 74-100 mg/dL

Assessment of changes in HOMA-IR over time. Ranges <1.0

Assessment of changes in triglycerides/HDL ratio over time. Ranges <2.0

Bristlecone Health, Inc.

University of Minnesota

To assess differences between the control and experimental groups, a mixed model will be fit for each variable separately using both baseline (week 0) and post program (week 36) values for each subject. Models will include week, group, and their interaction as fixed effects, gender as a covariate, and subject as random effect. To assess significant differences, we will use the difference at week 36 adjusted for the baseline difference, report p-values, least squares mean, and 95% confidence intervals. Further analysis of treatment effects over time will be examined by comparing the within-group differences over time.

The study will require 20 subjects.
Each subject will have one "study eye" that will be designated for treatment.
Subjects will be exposed to light emitted from Warp 10 LED's (Quantum Devices, Barneveld, WI) at wavelengths of 670 nm (+/-15nm) with a minimum exposure of 4 J/cm2 (4.0 - 7.68J/cm2). This is accomplished by applying the 50 mW/cm2 (50 - 80 mw/cm2) LED-generated light to the study eye.
Treatments involve application of the LED-generated light for 80 seconds, twice daily.
Primary efficacy and toxicity outcomes are determined by measuring excess retinal thickness via Ocular Coherence Tomography at 1 month, 3 months, and 6 months, prior to conclusion of the study.
• This protocol will be stopped if, at any point in the study, a 50% increase in excess retinal thickness is demonstrated via OCT in 25% of subjects in the experimental group.

Diabetic Macular Edema

Study Subjects will take the Warp 10 (LED) home and treat twice per day for three months

Warp 10 LED Device

Subjects will be exposed to light emitted from LED's at wavelengths of 670 nm (+/-15nm) with a minimum exposure of 4 J/cm2 (4.0 - 7.68J/cm2). This is accomplished by applying the 50 mW/cm2 (50 - 80 mw/cm2) LED-generated light to the study eye.
Treatments involve application of the LED-generated light for 80 seconds, twice daily.

Near-infrared light (NIR)

Medical College of Wisconsin

Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study

Phase 1 Study To Determine the Effects of Short Term Near-infrared Light (NIR) Therapy on Anatomic and Functional Abnormalities of Diabetic Macular Edema, and Assess Safety of Short Term Near-infrared Light Therapy in Eyes With Diabetic Macular Edema.

cytochrome c/ödem

Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention

Near-infrared Light (NIR) Therapy for Diabetic Macular Edema: A Pilot Study

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