Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

March 7, 2012 updated by: Yosanan Yospaiboon, Khon Kaen University
The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.

Study Overview

Status

Completed

Conditions

Detailed Description

To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

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

      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged between 20 and 80 years old
  • dark iris
  • require binocular indirect ophthalmoscopy for complete ocular examination
  • signed written consent forms

Exclusion Criteria:

  • history of ocular trauma
  • history of intraocular surgery
  • history of laser treatment
  • previous eye drop instillation that may affect pupillary dilation
  • ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis
  • history of diabetes mellitus, severe hypertension and cardiovascular diseases

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
single dose vs three doses of 1%tropicamide and 10%phenylephrine
single dose vs three doses of 1%tropicamide and 10%phenylephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
horizontal pupil diameter
Time Frame: 30 min
30 min

Secondary Outcome Measures

Outcome Measure
Time Frame
systolic blood pressure
Time Frame: 30 min
30 min
diastolic blood pressure
Time Frame: 30 min
30 min
heart rate
Time Frame: 30 min
30 min
adverse drug reaction
Time Frame: 30 min
30 min

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yosanan Yospaiboon, M.D., Faculty of Medicine, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

December 1, 2004

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

July 11, 2005

First Submitted That Met QC Criteria

July 15, 2005

First Posted (Estimate)

July 18, 2005

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

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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