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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120432

Enrollment

Registered

2005-07-18

Start date

2004-12-31

Completion date

2005-06-30

Last updated

2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases

Keywords

single dose, mydriatic drug, 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 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.

Interventions

DRUG1% tropicamide and 10% phenylephrine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
horizontal pupil diameter	30 min

Secondary

Measure	Time frame
systolic blood pressure	30 min
diastolic blood pressure	30 min
heart rate	30 min
adverse drug reaction	30 min

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026