Caffeine Consumption in Glaucoma Patients and Healthy Subjects

Wills Eye

Status: Enrolling

Conditions: Glaucoma, Primary Open Angle

Treatments: Dietary Supplement: Caffeine tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03675412

IRB#18-729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Glaucoma Patients

Active Comparator group

Description:

Eligible participants include patients with mild, moderate or advanced primary open angle glaucoma (POAG) or primary angle closure glaucoma (PACG). Each participant will complete baseline study tasks. Each participant will then receive one 200 mg caffeine tablet to ingest. Study tasks will be performed 1 hour and 2 hours after caffeine ingestion.

Treatment:

Dietary Supplement: Caffeine tablet

Healthy controls

Active Comparator group

Description:

Eligible participants include healthy subjects with no eye diseases. Each participant will complete baseline study tasks. Each participant will then receive one 200 mg caffeine tablet to ingest. Study tasks will be performed 1 hour and 2 hours after caffeine ingestion.

Treatment:

Dietary Supplement: Caffeine tablet