The Effects of Caffeinated Coffee on Intraocular Pressure

October 1, 2012 updated by: Massachusetts Eye and Ear Infirmary
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit
Participants will be given an 8 oz cup of caffeinated coffee on their first visit and 8 oz cup of decaffeinated coffee on their second visit.
Other: Caffeinated Coffee
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.
Other: Decaffeinated Coffee
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.
EXPERIMENTAL: Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit
Participants will be given an 8 oz cup of decaffeinated coffee on their first visit and 8 oz cup of caffeinated coffee on their second visit.
Other: Caffeinated Coffee
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.
Other: Decaffeinated Coffee
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prior to coffee ingestion (baseline), 60 minutes post 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
Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

June 1, 2011

First Posted (ESTIMATE)

June 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-06-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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