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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00120432
First received: July 11, 2005
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Eye Diseases
 Drug: 1% tropicamide and 10% phenylephrine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • horizontal pupil diameter [ Time Frame: 30 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • systolic blood pressure [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
  • diastolic blood pressure [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
  • heart rate [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
  • adverse drug reaction [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: December 2004
Study Completion Date: June 2005
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120432

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

Publications:

Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00120432     History of Changes
Other Study ID Numbers: HE461104
Study First Received: July 11, 2005
Last Updated: March 7, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

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

ClinicalTrials.gov processed this record on October 16, 2012