The Effect of Dosage of Caffeine on Intraocular Pressure

February 14, 2013 updated by: Damrong Wiwatwongwana, Chiang Mai University

The Effect of Dosage of Caffeine on Intraocular Pressure in Healthy Subjects

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Chiang Mai University Hospital
        • Contact:
        • Principal Investigator:
          • Damrong Wiwatwongwana, M.D.
        • Sub-Investigator:
          • Atchareeya Wiwatwongwana, M.D.
        • Sub-Investigator:
          • Muenploy Nipparak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Group1: Decaffeinated coffee
contains 0.5-2 mg of caffeine
Other: decaffeinated coffee
contains caffeine 0.5-2 mg
Active Comparator: Group2: regular dose coffee
contains 91.8 mg of caffeine
Other: regular dose coffee
contains 91.8 mg of caffeine
Active Comparator: Group3: high dose coffee
contains 144 mg of caffeine
Other: high dose coffee
contains 144 mg of caffeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in intraocular pressure (mmHg)after caffeine intake
Time Frame: 0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake

intraocular pressure measured at 4 timepoints:

  1. 0 minutes (baseline)
  2. 30 minutes after intake
  3. 60 minutes after intake
  4. 90 minutes after intake
0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Damrong Wiwatwongwana, M.D., Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPT-11-03-03A-12-X

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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