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A New More Efficient Cycloplegia Scheme

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ClinicalTrials.gov Identifier: NCT02177539
Recruitment Status : Unknown
Verified June 2014 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Refractive Errors Drug: Cyclopentolate Drug: Cyclopentolate+tropicamide+phenylephrine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: A New More Efficient Cycloplegia Scheme
Study Start Date : May 2014
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : September 2014


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 Name: Cyclogyl

Drug: Cyclopentolate+tropicamide+phenylephrine
New scheme. All drugs together and wait 30 minutes for retinoscopy
Other Name: 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 Name: Cyclogyl

Drug: Cyclopentolate+tropicamide+phenylephrine
New scheme. All drugs together and wait 30 minutes for retinoscopy
Other Name: Cyclogyl, Mydfrin, Mydriacyl




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Change in spherical refraction [ Time Frame: average 18 days ]
    Change in spherical refraction between visit 1 and 2.

  2. Change in cylindrical refraction [ Time Frame: average 18 days ]
    Change in cylindrical refraction between visit 1 and 2

  3. 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


Other Outcome Measures:
  1. crying with the application [ Time Frame: average 18 days ]
    does the child cry with both schemes?

  2. eyes color and cycloplegia [ Time Frame: average 18 days ]
    there is a difference between the effectiveness of the schemes according to eye color?



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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177539


Contacts
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Contact: Osvaldo H Berger, MD +56966076844 oberger@uc.cl

Locations
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Chile
Pontificia Universidad Catolica de Chile, Departamento de Oftalmología Recruiting
Santiago, Chile
Contact: Osvaldo H Berger, MD    +56966076844    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         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Study Chair: Cristian Salgado Pontificia Universidad Catolica de Chile

Publications:

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02177539     History of Changes
Other Study ID Numbers: 12-344
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014

Keywords provided by Pontificia Universidad Catolica de Chile:
cycloplegia
refraction in children
cycloplegic agents
cycloplegic schemes
cyclopentolate

Additional relevant MeSH terms:
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Tropicamide
Refractive Errors
Eye Diseases
Phenylephrine
Cyclopentolate
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Parasympatholytics