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The Effects of Caffeinated Coffee on Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01364207
First received: November 5, 2010
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  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 Blind (Subject, Investigator)
Official Title: The Effects of Caffeinated Coffee on Intraocular Pressure

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   40 Years to 89 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01364207     History of Changes
Other Study ID Numbers: 09-06-052
Study First Received: November 5, 2010
Results First Received: June 8, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013