The Effects of Caffeinated Coffee on Intraocular Pressure
1 other identifier
interventional
112
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 5, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
October 31, 2012
CompletedOctober 31, 2012
October 1, 2012
9 months
November 5, 2010
June 8, 2012
October 1, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Intraocular Pressure at 60 Minutes
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
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
Study Arms (2)
Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit
EXPERIMENTALParticipants 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.
Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit
EXPERIMENTALParticipants 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.
Interventions
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.
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 Criteria
You may qualify if:
- yrs
- POAG for cases or no forms of glaucoma for controls
- Willingness to drink coffee
- Consent signed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We gave subjects caffeinated coffee on one visit and decaffeinated coffee on the other visit. The changes in outcome parameters we observed (ie IOP changes) could be due to other non-caffeine components in the coffee.
Results Point of Contact
- Title
- Dr. Louis R. Pasquale
- Organization
- Massachusetts Eye and Ear Infirmary
Study Officials
- PRINCIPAL INVESTIGATOR
Louis R Pasquale, MD
Massachusetts Eye and Ear Infirmary
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2010
First Posted
June 2, 2011
Study Start
November 1, 2010
Primary Completion
August 1, 2011
Study Completion
June 1, 2012
Last Updated
October 31, 2012
Results First Posted
October 31, 2012
Record last verified: 2012-10