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The Effects of Caffeinated Coffee on Intraocular Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364207
First Posted: June 2, 2011
Last Update Posted: October 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
  Purpose
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.

Condition Intervention
Primary Open Angle Glaucoma Other: Caffeinated Coffee Other: Decaffeinated Coffee

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: The Effects of Caffeinated Coffee on Intraocular Pressure

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • 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



Enrollment: 112
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364207


Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Louis R Pasquale, MD Massachusetts Eye and Ear Infirmary
  More Information

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01364207     History of Changes
Other Study ID Numbers: 09-06-052
First Submitted: November 5, 2010
First Posted: June 2, 2011
Results First Submitted: June 8, 2012
Results First Posted: October 31, 2012
Last Update Posted: October 31, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases