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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

July 11, 2005
March 7, 2012
December 2004
Not Provided
horizontal pupil diameter [ Time Frame: 30 min ] [ Designated as safety issue: No ]
horizontal pupil diameter
Complete list of historical versions of study NCT00120432 on ClinicalTrials.gov Archive Site
  • 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 ]
  • systolic blood pressure
  • diastolic blood pressure
  • heart rate
  • adverse drug reaction
  • time to pupil dilation greater than 6 mm
Not Provided
Not Provided
 
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Eye Diseases
Drug: 1% tropicamide and 10% phenylephrine
single dose vs three doses of 1%tropicamide and 10%phenylephrine
Active Comparator: A
single dose vs three doses of 1%tropicamide and 10%phenylephrine
Intervention: Drug: 1% tropicamide and 10% phenylephrine
Ratanapakorn T, Yospaiboon Y, Chaisrisawadsuk N. Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. J Med Assoc Thai. 2006 Nov;89(11):1934-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2005
Not Provided

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00120432
HE461104
Yes
Yosanan Yospaiboon, Khon Kaen University
Khon Kaen University
Not Provided
Principal Investigator: Yosanan Yospaiboon, M.D. Faculty of Medicine, Khon Kaen University
Khon Kaen University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP