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The Effects of Caffeinated Coffee on Intraocular Pressure

Not Applicable
Completed
Conditions
Primary Open Angle Glaucoma
Interventions
Other: Caffeinated Coffee
Other: Decaffeinated Coffee
Registration Number
NCT01364207
Lead Sponsor
Massachusetts Eye and Ear Infirmary
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
112
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd VisitCaffeinated CoffeeParticipants 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.
Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd VisitDecaffeinated CoffeeParticipants 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 VisitCaffeinated CoffeeParticipants 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.
Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd VisitDecaffeinated CoffeeParticipants 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.
Primary Outcome Measures
NameTimeMethod
Change in Intraocular Pressure at 60 MinutesPrior 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 MinutesPrior 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary

🇺🇸

Boston, Massachusetts, United States

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