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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014