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Clinical Trials/NCT01793311
NCT01793311UnknownNot Applicable

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

Chiang Mai University2 sites in 1 country60 target enrollmentStarted: February 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
2
Primary Endpoint
change from baseline in intraocular pressure (mmHg)after caffeine intake

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Damrong Wiwatwongwana

M.D.

Chiang Mai University

Study Sites (2)

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