Caffeine Consumption in Glaucoma Patients and Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caffeine tablet.
- Who it may be relevant to
- Registry conditions: Glaucoma, Primary Open Angle. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acute Changes in Optic Nerve Head (ONH) and Macular Blood Flow After Caffeine Consumption in Glaucoma Patients and Healthy Subjects: A Quantitative Optic Coherence Tomography Angiography (OCTA) Study
Overview
Caffeine is the most widely consumed drinking nutrient in the world. Caffeine effects various organs and the vascular system. It decreases ocular blood flow due to vasoconstriction.
Detailed description
Ingestion of caffeine in glaucoma patients and healthy subjects may decrease peripapillary and macular blood flow in the back of the eye.
The primary objective of this study is to assess the acute changes in peripapillary and macular blood flow before and after an intake of oral caffeine (200 milligram tablet) in glaucoma patients and healthy subjects by using optical coherence tomography angiography (OCTA) scans. This novel imaging tool creates three-dimensional angiograms to assesses signal changes caused by flowing blood cells in a non-invasive angiogram scan. Blood flow is shown as vessel density measured in percentage.
Interventions
- Dietary supplement Caffeine tablet
Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.
Primary outcome measures
- Blood flow change in back of eye before and after caffeine [Time frame: Baseline, Hour 1, Hour 2]
Eligibility criteria
Inclusion criteria
- age 18 to 90 years
- diagnosis of primary open angle glaucoma (Mild, Moderate and Advanced)
- healthy subjects with no eye disease
Exclusion criteria
- Diseases, ophthalmic or systemic, that are likely to affect OCTA results
- greater than moderate cataract
- nystagmus
- inability to look at target
- macular degeneration other than mild drusen or pigmentary changes
- diabetic retinopathy
- neovascular glaucoma or non-glaucoma optic neuropathies
- current macular edema, prior laser to retina, inflammatory retinopathy or choroidopathy
- keratoconus, corneal ectasia, central corneal scarring
- rheumatologic diseases or Raynaud's phenomena
- pregnant and lactating women
- mental illness or alcohol addiction
- pre-existing bladder symptoms, cardiac disease or sleep disorder
- refractive spherical diopter greater than 5 or cylinder greater than 3
- possible tolerance to caffeine (drinking more than 1 cup coffee per day).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Wills Eye Glaucoma Service — Philadelphia
Identifiers
NCT: NCT03675412 · IRB#18-729