Boston, Massachusetts 02114


Purpose:

High intraocular pressure (IOP) is a known risk factor for developing primary open-angle glaucoma (POAG). Caffeine intake has been shown to increase IOP. The investigators hypothesize that the effects of caffeine intake on IOP are different in certain populations.


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


Study is Available At:


Original ID:

09-06-052


NCT ID:

NCT01364207


Secondary ID:


Study Acronym:


Brief Title:

The Effects of Caffeinated Coffee on Intraocular Pressure


Official Title:

The Effects of Caffeinated Coffee on Intraocular Pressure


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

89 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts Eye and Ear Infirmary


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Louis R Pasquale, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary
Primary Contact:Aliya Jiwani, BA
6175734240 ext. 4240
6175734240
aliya_jiwani@meei.harvard.edu

Study Dates

Start Date:November 2010
Completion Date:July 2012
Completion Type:Anticipated
Primary Completion Date:July 2012
Primary Completion Type:Anticipated
Verification Date:April 2012
Last Changed Date:April 19, 2012
First Received Date:November 5, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Intraocular pressure
Time Frame:Before (baseline) and 60 and 90 min after coffee consumption.
Safety Issues:False
Description:Intraocular pressure (IOP) will be measured using a Pascal Dynamic Contour Tonometer (DCT).

Study Interventions

Intervention Type:Other
Name:Caffeinated Coffee
Description: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.
Arm Name:Caffeinated Coffee
Intervention Type:Other
Name:Decaffeinated Coffee
Description: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.
Arm Name:Decaffeinated Coffee

Study Arms

Study Arm Type:Experimental
Arm Name:Decaffeinated Coffee
Description:Participants will be given an 8 oz cup of decaffeinated coffee.
Study Arm Type:Experimental
Arm Name:Caffeinated Coffee
Description:Participants will be given an 8 oz cup of caffeinated coffee.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts Eye and Ear Infirmary

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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