A New More Efficient Cycloplegia Scheme

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02177539

Enrollment

Registered

2014-06-27

Start date

2014-05-31

Completion date

2014-09-30

Last updated

2014-06-27

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

Conditions

Refractive Errors

Keywords

cycloplegia, refraction in children, cycloplegic agents, cycloplegic schemes, cyclopentolate

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)

Interventions

DRUGCyclopentolate

Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.

DRUGCyclopentolate+tropicamide+phenylephrine

New scheme. All drugs together and wait 30 minutes for retinoscopy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 10 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
crying with the application	average 18 days	does the child cry with both schemes?
eyes color and cycloplegia	average 18 days	there is a difference between the effectiveness of the schemes according to eye color?

Countries

Chile

Contacts

Primary ContactOsvaldo H Berger, MD

oberger@uc.cl+56966076844

Outcome results

None listed

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