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Caffeine Consumption in Glaucoma Patients and Healthy Subjects

NCT03675412 · Wills Eye
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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
About this study
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.
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).
Study design
Enrollment target: 80 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-12-30
Estimated completion: 2026-12-31
Last updated: 2025-11-14
Interventions
Dietary Supplement: Caffeine tablet
Primary outcomes
  • Blood flow change in back of eye before and after caffeine (Baseline, Hour 1, Hour 2)
Sponsor
Wills Eye · other
Contacts & investigators
ContactM. Reza Razeghinejad, MD · contact · mrazeghi@willseye.org · 215-928-7023
ContactJeanne Molineaux, COA · contact · jmolineaux@gwillseye.org · 215-825-4713
InvestigatorM. Reza Razeghinejad, MD · principal_investigator, Wills Eye Hospital
All locations (1)
Wills Eye Glaucoma ServiceRecruiting
Philadelphia, Pennsylvania, United States
Caffeine Consumption in Glaucoma Patients and Healthy Subjects · TrialPath