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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120432
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2004
Actual Study Completion Date : June 2005

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

Primary Outcome Measures :
  1. horizontal pupil diameter [ Time Frame: 30 min ]

Secondary Outcome Measures :
  1. systolic blood pressure [ Time Frame: 30 min ]
  2. diastolic blood pressure [ Time Frame: 30 min ]
  3. heart rate [ Time Frame: 30 min ]
  4. adverse drug reaction [ Time Frame: 30 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120432

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Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
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Principal Investigator: Yosanan Yospaiboon, M.D. Faculty of Medicine, Khon Kaen University

Publications of Results:
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Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University Identifier: NCT00120432     History of Changes
Other Study ID Numbers: HE461104
First Posted: July 18, 2005    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Yosanan Yospaiboon, Khon Kaen University:
single dose
mydriatic drug
pupillary dilation

Additional relevant MeSH terms:
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Eye Diseases
Dilatation, Pathologic
Pathological Conditions, Anatomical
Pupil Disorders
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents