A New More Efficient Cycloplegia Scheme

Phase 4

• Conditions: Refractive Errors
• Interventions: Drug: Cyclopentolate; Drug: Cyclopentolate+tropicamide+phenylephrine

• Registration Number: NCT02177539
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-27
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Study First Posted: 2014-06-27
• Last Update Posted: 2014-06-27
• Primary Completion: 2014-08
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclopentolate	Cyclopentolate+tropicamide+phenylephrine	-
Cyclopentolate	Cyclopentolate	-
Cyclopentolate+tropicamide+phenylephrine	Cyclopentolate	-
Cyclopentolate+tropicamide+phenylephrine	Cyclopentolate+tropicamide+phenylephrine	-

Primary Outcome Measures

Name	Time	Method
Change in Spherical equivalent	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.

Secondary Outcome Measures

Name	Time	Method
Change in spherical refraction	average 18 days	Change in spherical refraction between visit 1 and 2.
Change in cylindrical refraction	average 18 days	Change in cylindrical refraction between visit 1 and 2
iris motility	average 18 days	both schemes are effective in cycloplegia ? In visit 1 and 2 the iris motility after the cyclopegic schemes will be evaluated

Trial Locations

Locations (1)

Pontificia Universidad Catolica de Chile, Departamento de Oftalmología; 🇨🇱 Santiago, Chile