A New More Efficient Cycloplegia Scheme

Pontificia Universidad Catolica de Chile1 site in 1 country30 target enrollmentMay 2014

ConditionsRefractive Errors

InterventionsCyclopentolate Cyclopentolate+tropicamide+phenylephrine

DrugsCyclopentolate Cyclopentolate+tropicamide+phenylephrine

Overview

Phase: Phase 4
Intervention: Cyclopentolate
Conditions: Refractive Errors
Sponsor: Pontificia Universidad Catolica de Chile
Enrollment: 30
Locations: 1
Primary Endpoint: Change in Spherical equivalent
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pontificia Universidad Catolica de Chile

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children between 1 and 10 years

Exclusion Criteria

•Strabismus
•Ocular surgery
•Another ocular disease than ametropias (i.e uveitis, cataract)
•Cardiovascular or neurologic disease.
•Allergy to any of drugs used in the study

Arms & Interventions

Cyclopentolate

Intervention: Cyclopentolate

Cyclopentolate

Intervention: Cyclopentolate+tropicamide+phenylephrine

Cyclopentolate+tropicamide+phenylephrine

Intervention: Cyclopentolate

Cyclopentolate+tropicamide+phenylephrine

Intervention: Cyclopentolate+tropicamide+phenylephrine

Outcomes

Primary Outcomes

Change in Spherical equivalent

Time Frame: average 18 days

In the first and second visit the spherical equivalent will be measured with retinoscopy. Change in spherical equivalent refraction from first visit to day average 18 days (second visit). On both visits the patient will receive different cyclopegia schemes.