The Effects of Caffeinated Coffee on Intraocular Pressure

High intraocular pressure (IOP) is a known risk factor for developing primary open-angle glaucoma (POAG). There is controversy in the literature regarding the degree to which caffeine influences IOP, with some studies reporting minimal changes in IOP while others report up to 4 mmHg increases. To date there are no double-masked randomized controlled trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for primary open-angle glaucoma. The investigators aim to better understand the relationship between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a double-masked, crossover randomized controlled clinical trial.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

40-89 yrs
POAG for cases or no forms of glaucoma for controls
Willingness to drink coffee
Consent signed

Exclusion criteria

Age less than 40 or greater than 89 yrs
all forms of glaucoma other than POAG
any condition inappropriate for tonometry (ie corneal disease, LASIK)
unable or unwilling to give consent
unable or unwilling to drink coffee
pregnancy

Treatment and study plan

Caffeinated coffee

Other

Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.

Decaffeinated coffee

Other

Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.

Primary outcomes

Change in Intraocular Pressure at 60 Minutes

Time frame: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion

At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion

At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion
Change in Intraocular Pressure at 90 Minutes

Time frame: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion

At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion

At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Jun 2, 2011
Registry last updated: Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed