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The Effect of Dosage of Caffeine on Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01793311
Recruitment Status : Unknown
Verified February 2013 by Damrong Wiwatwongwana, Chiang Mai University.
Recruitment status was:  Recruiting
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Damrong Wiwatwongwana, Chiang Mai University

Brief 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.


Condition or disease Intervention/treatment Phase
Intraocular Pressure Caffeine Dosage Other: decaffeinated coffee Other: regular dose coffee Other: high dose coffee Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Dosage of Caffeine on Intraocular Pressure in Healthy Subjects
Study Start Date : February 2013
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793311


Contacts
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Contact: Damrong Wiwatwongwana, M.D. 6653945512 ext 5515 samseeha@hotmail.com

Locations
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Thailand
Chiang Mai University Hospital Recruiting
Muang, Chiang Mai, Thailand, 50200
Contact: Damrong Wiwatwongwana, M.D.    6653945512 ext 5515    samseeha@hotmail.com   
Principal Investigator: Damrong Wiwatwongwana, M.D.         
Sub-Investigator: Atchareeya Wiwatwongwana, M.D.         
Sub-Investigator: Muenploy Nipparak         
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Damrong Wiwatwongwana, M.D. Chiang Mai University

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Responsible Party: Damrong Wiwatwongwana, M.D., Chiang Mai University
ClinicalTrials.gov Identifier: NCT01793311    
Other Study ID Numbers: OPT-11-03-03A-12-X
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Damrong Wiwatwongwana, Chiang Mai University:
intraocular pressure
caffeine
dosage
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents