NCT00120432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

First QC Date

July 11, 2005

Last Update Submit

March 7, 2012

Conditions

Eye Diseases

Keywords

single dosemydriatic drugpupillary dilation

Outcome Measures

Primary Outcomes (1)

  • horizontal pupil diameter

    30 min

Secondary Outcomes (4)

  • systolic blood pressure

    30 min

  • diastolic blood pressure

    30 min

  • heart rate

    30 min

  • adverse drug reaction

    30 min

Study Arms (1)

A

ACTIVE COMPARATOR

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

Drug: 1% tropicamide and 10% phenylephrine

Interventions

1% tropicamide and 10% phenylephrineDRUG

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

A

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 20 and 80 years old
  • dark iris
  • require binocular indirect ophthalmoscopy for complete ocular examination
  • signed written consent forms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 17205877RESULT

MeSH Terms

Conditions

Eye DiseasesMydriasis

Interventions

TropicamidePhenylephrine

Condition Hierarchy (Ancestors)

Pupil Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Yosanan Yospaiboon, M.D.

    Faculty of Medicine, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 18, 2005

Study Start

December 1, 2004

Study Completion

June 1, 2005

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

TH(1)