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NCT01793311 Clinical Trial

The Effect of Dosage of Caffeine on Intraocular Pressure

Intraocular Pressure Clinical Trial

Official title:
The Effect of Dosage of Caffeine on Intraocular Pressure in Healthy Subjects

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01793311
Other study ID # OPT-11-03-03A-12-X
Secondary ID
Status Unknown status
Phase N/A
First received February 13, 2013
Last updated February 14, 2013
Start date February 2013
Est. completion date March 2013

Study information
Verified date February 2013
Source Chiang Mai University
Contact Damrong Wiwatwongwana, M.D.
Phone 6653945512
Email samseeha@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of the study is to determine the effect of different doses of caffeine on intraocular pressure. We hypothesized that higher dosage of caffeine would increase intraocular pressure more than lower doses.

Eligible subjects will be randomized into three groups:

1. group 1: intake of decaffeinated coffee

2. group 2: intake of coffee with lower caffeine dose

3. group 3: intake of coffee with higher caffeine dose

Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.

Description:

decaffeinated coffee contains 0.5-2 mg of caffeine regular dose coffee contains 91.8 mg of caffeine high dose coffee contains 144 mg of caffeine

all three groups' intraocular pressure will be measured with the Goldmann applanation tonometer at 4 timepoints:

1. 0 minutes (baseline)

2. 30 minutes after intake

3. 60 minutes after intake

4. 90 minutes after intake

Recruitment information / eligibility
Status Unknown status
Enrollment 60
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- healthy subjects

- normal central corneal thickness

- normal baseline intraocular pressure

Exclusion Criteria:

- any ocular disease

- baseline intraocular pressure over 21 mmHg

- central corneal thickness less than 520 microns or more than 540 microns

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• decaffeinated coffee
contains caffeine 0.5-2 mg
• regular dose coffee
contains 91.8 mg of caffeine
• high dose coffee
contains 144 mg of caffeine

Locations
Country Name City State
Thailand Chiang Mai University Hospital Muang Chiang Mai

Sponsors (1)
Lead Sponsor Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline in intraocular pressure (mmHg)after caffeine intake intraocular pressure measured at 4 timepoints:
0 minutes (baseline)
30 minutes after intake
60 minutes after intake
90 minutes after intake		 0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake
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