The Effects of Caffeinated Coffee on Intraocular Pressure

Primary Open Angle Glaucoma Clinical Trial

Official title:

The Effects of Caffeinated Coffee on Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364207
• Other study ID #: 09-06-052
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: October 1, 2012
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 89 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No