- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120432
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
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Pupil Disorders
- Eye Diseases
- Dilatation, Pathologic
- Mydriasis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
- Tropicamide
Other Study ID Numbers
- HE461104
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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