Clinical trial NCT03675412: Caffeine Consumption in Glaucoma Patients and Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Primary Open Angle
Keywords: Primary Open Angle Glaucoma (POAG)
Optical Coherence Tomography Angiography (OCTA)
Caffeine
Macular Blood Flow
Peripapillary Blood Flow
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All eyes will undergo imaging to measure blood flow in the back of the eye (retina and optic nerve) using the Avanti AngioVue HD OCTA (optical coherence tomography angiography)
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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).

Primary outcomes:
measure: Blood flow change in back of eye before and after caffeine
timeFrame: Baseline, Hour 1, Hour 2
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: M. Reza Razeghinejad, MD
role: PRINCIPAL_INVESTIGATOR
References: