A New More Efficient Cycloplegia Scheme

Pontificia Universidad Catolica de Chile

Status and phase: Unknown; Phase 4

Conditions: Refractive Errors

Treatments: Drug: Cyclopentolate; Drug: Cyclopentolate+tropicamide+phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02177539

12-344

Details and patient eligibility

About

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)

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Cyclopentolate

Active Comparator group

Treatment:

Drug: Cyclopentolate+tropicamide+phenylephrine

Drug: Cyclopentolate

Cyclopentolate+tropicamide+phenylephrine

Experimental group

Treatment:

Drug: Cyclopentolate+tropicamide+phenylephrine

Drug: Cyclopentolate