Metabolic Mapping to Measure Retinal Metabolism

Completed · Phase 2

Conditions studied: Macular Degeneration, Diabetic Retinopathy, Hippel-Landau Disease, Mitochondria

In brief

This study will test whether a new non-invasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use). The retina is the part of the eye that sends information to the brain. Participants in current NEI studies who have age-related macular degeneration (AMD), diabetic retinopathy, or von Hippel-Landau disease may be eligible for this study. Healthy volunteers will participate as controls. Patients with AMD must be 60 years of age or older; those with VHL disease or diabetic retinopathy must be 18 or older. Participants undergo the tests and procedures required in the NEI study in which they previously enrolled. In addition, for the current study, they undergo metabolic mapping. For this procedure, the subject's eyes are dilated, and different amounts of low-level light are shone into the eye to see how different cells respond with changes in metabolism. Measurements are taken while the subject breathes room air and while he or she breathes medical grade oxygen for about 1 minute. The entire procedure takes about 15 minutes.

Key facts

Study ID

NCT00385333

Run by

National Eye Institute (NEI)

People needed

28

Starts

2006-09-29

Expected to finish

2010-09-16

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• GENERAL EXCLUSION CRITERIA:
• Cataract surgery in the study eye.
• Glaucoma with evidence of optic nerve damage.
• Chronic requirement for any systemic or ocular medication for other eye diseases other than AMD, DR, or VHL-disease.
• Presence of implanted medical devices that may be affected by electromagnetic frequency (EMF) emissions. Although our equipment is CE or UL rated for EMF emissions it would be prudent to exclude people with implanted pacemakers, neural stimulators, and insulin pumps.
• Arrhythmia as indicated in medical records, as this may result in instability in measurements.
• History of seizures. The scanning mechanism of the system operates at 12 Hz, which may induce a seizure (n.b. a 12Hz scan rate is used in the Heidelberg HRTII and HRA).
• Presence of chronic obstructive pulmonary disease (COPD) or other lung disease that might make breathing 100% O2 unsafe.
• Ocular disease (other than AMD, DR, or VHL) that confounds assessment of the retina. These include but are not limited to central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
• Vitreous hemorrhage.
• History of renal failure requiring dialysis or renal transplant.
• Existing condition that in the opinion of the investigator would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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