The Effect of Dosage of Caffeine on Intraocular Pressure

NCT ID: NCT01793311

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-03-31

Brief Summary

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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

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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

Conditions

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Intraocular Pressure Caffeine Dosage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group1: Decaffeinated coffee

contains 0.5-2 mg of caffeine

Group Type SHAM_COMPARATOR

decaffeinated coffee

Intervention Type OTHER

contains caffeine 0.5-2 mg

Group2: regular dose coffee

contains 91.8 mg of caffeine

Group Type ACTIVE_COMPARATOR

regular dose coffee

Intervention Type OTHER

contains 91.8 mg of caffeine

Group3: high dose coffee

contains 144 mg of caffeine

Group Type ACTIVE_COMPARATOR

high dose coffee

Intervention Type OTHER

contains 144 mg of caffeine

Interventions

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decaffeinated coffee

contains caffeine 0.5-2 mg

Intervention Type OTHER

regular dose coffee

contains 91.8 mg of caffeine

Intervention Type OTHER

high dose coffee

contains 144 mg of caffeine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Damrong Wiwatwongwana

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Damrong Wiwatwongwana, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

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Chiang Mai University Hospital

Muang, Chiang Mai, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Damrong Wiwatwongwana, M.D.

Role: CONTACT

6653945512 ext. 5515

Facility Contacts

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Damrong Wiwatwongwana, M.D.

Role: primary

6653945512 ext. 5515

Other Identifiers

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OPT-11-03-03A-12-X

Identifier Type: -

Identifier Source: org_study_id

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