A New More Efficient Cycloplegia Scheme

June 25, 2014 updated by: Pontificia Universidad Catolica de Chile
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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Pontificia Universidad Catolica de Chile, Departamento de Oftalmología
        • Contact:
          • Osvaldo H Berger, MD
          • Phone Number: +56966076844
          • Email: oberger@uc.cl
        • Sub-Investigator:
          • Pablo Altschwager, MD
        • Principal Investigator:
          • Osvaldo H Berger, MD
        • Principal Investigator:
          • Cristian Salgado, MD
        • Sub-Investigator:
          • Bernardita Alamos, MD
        • Sub-Investigator:
          • Silvia Araneda, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cyclopentolate
Drug: Cyclopentolate
Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.
Other Names:
  • Cyclogyl
Drug: Cyclopentolate+tropicamide+phenylephrine
New scheme. All drugs together and wait 30 minutes for retinoscopy
Other Names:
  • Cyclogyl, Mydfrin, Mydriacyl
Experimental: Cyclopentolate+tropicamide+phenylephrine
Drug: Cyclopentolate
Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.
Other Names:
  • Cyclogyl
Drug: Cyclopentolate+tropicamide+phenylephrine
New scheme. All drugs together and wait 30 minutes for retinoscopy
Other Names:
  • Cyclogyl, Mydfrin, Mydriacyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
average 18 days

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Study Chair: Cristian Salgado, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-344

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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