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Completed

NCT Number: NCT00120432

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% tropicamide and 10% phenylephrine

Drug

single dose vs three doses of 1%tropicamide and 10%phenylephrine

Primary outcomes

  1. horizontal pupil diameter

    Time frame: 30 min

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Jul 18, 2005
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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