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

Primary Purpose

Eye Diseases

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
1% tropicamide and 10% phenylephrine
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Diseases focused on measuring single dose, mydriatic drug, pupillary dilation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Srinagarind Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

horizontal pupil diameter

Secondary Outcome Measures

systolic blood pressure
diastolic blood pressure
heart rate
adverse drug reaction

Full Information

First Posted
July 11, 2005
Last Updated
March 7, 2012
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT00120432
Brief Title
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Official Title
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
single dose, mydriatic drug, pupillary dilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
single dose vs three doses of 1%tropicamide and 10%phenylephrine
Intervention Type
Drug
Intervention Name(s)
1% tropicamide and 10% phenylephrine
Intervention Description
single dose vs three doses of 1%tropicamide and 10%phenylephrine
Primary Outcome Measure Information:
Title
horizontal pupil diameter
Time Frame
30 min
Secondary Outcome Measure Information:
Title
systolic blood pressure
Time Frame
30 min
Title
diastolic blood pressure
Time Frame
30 min
Title
heart rate
Time Frame
30 min
Title
adverse drug reaction
Time Frame
30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosanan Yospaiboon, M.D.
Organizational Affiliation
Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
17205877
Citation
Ratanapakorn T, Yospaiboon Y, Chaisrisawadsuk N. Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. J Med Assoc Thai. 2006 Nov;89(11):1934-9.
Results Reference
result

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

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