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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014