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The Effects of Caffeinated Coffee on Intraocular Pressure

NCT ID: NCT01364207

Last Updated: 2012-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Caffeinated Coffee

Intervention Type OTHER

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

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Caffeinated Coffee

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louis R Pasquale, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

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Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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09-06-052

Identifier Type: -

Identifier Source: org_study_id