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CompletedNCT00120432Updated Mar 9, 2012

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

A Phase 3 interventional study of 1% tropicamide and 10% phenylephrine in Eye Diseases, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by Khon Kaen University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Eye Diseases

Keywords

  • single dose
  • mydriatic drug
  • pupillary dilation
03

In context

Eye Diseases

388 studies on the registry are indexed under Eye Diseases; 62 are open to participants now.

This study's enrollment of 80 is above the median of 62 across 269 interventional studies indexed under Eye Diseases.

Browse Eye Diseases studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 161 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    A

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

    Drug: 1% tropicamide and 10% phenylephrine

Interventions

  • Drug1% tropicamide and 10% phenylephrine

    Drug pages: Tropicamide · Phenylephrine

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

06

What researchers measure

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

07

Study locations

1 site
  • Srinagarind Hospital
    Khon Kaen, 40002, Thailand
08

References and documents

Publications

  • 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. PubMed 17205877 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2004 and a completion of Jun 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2005
First posted
Jul 18, 2005
Start
Dec 2004
CompletionActual
Jun 2005
Last update
Mar 9, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00120432
Responsible party
Yosanan Yospaiboon (Professor, Khon Kaen University) — Principal investigator
First posted
Jul 18, 2005
Start date
Dec 2004
Completion
Jun 2005
Last update
Mar 9, 2012

Study contacts

Yosanan Yospaiboon, M.D.
principal investigator · Faculty of Medicine, Khon Kaen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Tropicamide · Phenylephrine

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