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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Khon Kaen University

Current Primary Outcome: horizontal pupil diameter [ Time Frame: 30 min ]

Original Primary Outcome: horizontal pupil diameter

Current Secondary Outcome:

  • systolic blood pressure [ Time Frame: 30 min ]
  • diastolic blood pressure [ Time Frame: 30 min ]
  • heart rate [ Time Frame: 30 min ]
  • adverse drug reaction [ Time Frame: 30 min ]


Original Secondary Outcome:

  • systolic blood pressure
  • diastolic blood pressure
  • heart rate
  • adverse drug reaction
  • time to pupil dilation greater than 6 mm


Information By: Khon Kaen University

Dates:
Date Received: July 11, 2005
Date Started: December 2004
Date Completion:
Last Updated: March 7, 2012
Last Verified: March 2012