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

Sponsor

Khon Kaen University (Other)

Overall Status

Completed

CT.gov ID

NCT00120432

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Drug: 1% tropicamide and 10% phenylephrine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2004

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: A

single dose vs three doses of 1%tropicamide and 10%phenylephrine

Drug: 1% tropicamide and 10% phenylephrine

single dose vs three doses of 1%tropicamide and 10%phenylephrine

Outcome Measures

Primary Outcome Measures

horizontal pupil diameter [30 min]

Secondary Outcome Measures

systolic blood pressure [30 min]
diastolic blood pressure [30 min]
heart rate [30 min]
adverse drug reaction [30 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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