Back to resultsA New More Efficient Cycloplegia Scheme
Primary Purpose
Refractive Errors
Status
Unknown status
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Cyclopentolate
Cyclopentolate+tropicamide+phenylephrine
Sponsored by
About this trial
This is an interventional diagnostic trial for Refractive Errors focused on measuring cycloplegia, refraction in children, cycloplegic agents, cycloplegic schemes, cyclopentolate
Eligibility 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
Sites / Locations
- Pontificia Universidad Catolica de Chile, Departamento de OftalmologíaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cyclopentolate
Cyclopentolate+tropicamide+phenylephrine
Arm Description
Outcomes
Primary Outcome Measures
Change in Spherical equivalent
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
Change in spherical refraction
Change in spherical refraction between visit 1 and 2.
Change in cylindrical refraction
Change in cylindrical refraction between visit 1 and 2
iris motility
both schemes are effective in cycloplegia ? In visit 1 and 2 the iris motility after the cyclopegic schemes will be evaluated
Full Information
NCT ID
NCT02177539
First Posted
May 27, 2014
Last Updated
June 25, 2014
Sponsor
Pontificia Universidad Catolica de Chile
1. Study Identification
Unique Protocol Identification Number
NCT02177539
Brief Title
A New More Efficient Cycloplegia Scheme
Official Title
A New More Efficient Cycloplegia Scheme
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
cycloplegia, refraction in children, cycloplegic agents, cycloplegic schemes, cyclopentolate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyclopentolate
Arm Type
Active Comparator
Arm Title
Cyclopentolate+tropicamide+phenylephrine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cyclopentolate
Other Intervention Name(s)
Cyclogyl
Intervention Description
Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.
Intervention Type
Drug
Intervention Name(s)
Cyclopentolate+tropicamide+phenylephrine
Other Intervention Name(s)
Cyclogyl, Mydfrin, Mydriacyl
Intervention Description
New scheme. All drugs together and wait 30 minutes for retinoscopy
Primary Outcome Measure Information:
Title
Change in Spherical equivalent
Description
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.
Time Frame
average 18 days
Secondary Outcome Measure Information:
Title
Change in spherical refraction
Description
Change in spherical refraction between visit 1 and 2.
Time Frame
average 18 days
Title
Change in cylindrical refraction
Description
Change in cylindrical refraction between visit 1 and 2
Time Frame
average 18 days
Title
iris motility
Description
both schemes are effective in cycloplegia ? In visit 1 and 2 the iris motility after the cyclopegic schemes will be evaluated
Time Frame
average 18 days
Other Pre-specified Outcome Measures:
Title
crying with the application
Description
does the child cry with both schemes?
Time Frame
average 18 days
Title
eyes color and cycloplegia
Description
there is a difference between the effectiveness of the schemes according to eye color?
Time Frame
average 18 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osvaldo H Berger, MD
Phone
+56966076844
Email
oberger@uc.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian Salgado
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Study Chair
Facility Information:
Facility Name
Pontificia Universidad Catolica de Chile, Departamento de Oftalmología
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osvaldo H Berger, MD
Phone
+56966076844
Email
oberger@uc.cl
First Name & Middle Initial & Last Name & Degree
Pablo Altschwager, MD
First Name & Middle Initial & Last Name & Degree
Osvaldo H Berger, MD
First Name & Middle Initial & Last Name & Degree
Cristian Salgado, MD
First Name & Middle Initial & Last Name & Degree
Bernardita Alamos, MD
First Name & Middle Initial & Last Name & Degree
Silvia Araneda, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15498055
Citation
Fan DS, Rao SK, Ng JS, Yu CB, Lam DS. Comparative study on the safety and efficacy of different cycloplegic agents in children with darkly pigmented irides. Clin Exp Ophthalmol. 2004 Oct;32(5):462-7. doi: 10.1111/j.1442-9071.2004.00863.x.
Results Reference
background
PubMed Identifier
23986630
Citation
McMullen M, Netland PA. Wait time as a driver of overall patient satisfaction in an ophthalmology clinic. Clin Ophthalmol. 2013;7:1655-60. doi: 10.2147/OPTH.S49382. Epub 2013 Aug 20.
Results Reference
background
PubMed Identifier
17534806
Citation
Bagheri A, Givrad S, Yazdani S, Reza Mohebbi M. Optimal dosage of cyclopentolate 1% for complete cycloplegia: a randomized clinical trial. Eur J Ophthalmol. 2007 May-Jun;17(3):294-300. doi: 10.1177/112067210701700303.
Results Reference
background
PubMed Identifier
1513131
Citation
Alimgil ML, Erda N. [The cycloplegic effect of atropine in comparison with the cyclopentolate-tropicamide-phenylephrine combination]. Klin Monbl Augenheilkd. 1992 Jul;201(1):9-11. doi: 10.1055/s-2008-1045860. German.
Results Reference
background
PubMed Identifier
17325142
Citation
Ebri A, Kuper H, Wedner S. Cost-effectiveness of cycloplegic agents: results of a randomized controlled trial in nigerian children. Invest Ophthalmol Vis Sci. 2007 Mar;48(3):1025-31. doi: 10.1167/iovs.06-0604.
Results Reference
background
PubMed Identifier
8414387
Citation
Manny RE, Fern KD, Zervas HJ, Cline GE, Scott SK, White JM, Pass AF. 1% Cyclopentolate hydrochloride: another look at the time course of cycloplegia using an objective measure of the accommodative response. Optom Vis Sci. 1993 Aug;70(8):651-65. doi: 10.1097/00006324-199308000-00013.
Results Reference
background
PubMed Identifier
11349929
Citation
Twelker JD, Mutti DO. Retinoscopy in infants using a near noncycloplegic technique, cycloplegia with tropicamide 1%, and cycloplegia with cyclopentolate 1%. Optom Vis Sci. 2001 Apr;78(4):215-22. doi: 10.1097/00006324-200104000-00010.
Results Reference
background
PubMed Identifier
10082056
Citation
Kleinstein RN, Mutti DO, Manny RE, Shin JA, Zadnik K. Cycloplegia in African-American children. Optom Vis Sci. 1999 Feb;76(2):102-7. doi: 10.1097/00006324-199902000-00017.
Results Reference
background
PubMed Identifier
2034449
Citation
Jones LW, Hodes DT. Possible allergic reactions to cyclopentolate hydrochloride: case reports with literature review of uses and adverse reactions. Ophthalmic Physiol Opt. 1991 Jan;11(1):16-21.
Results Reference
background
PubMed Identifier
7039329
Citation
Rengstorff RH, Doughty CB. Mydriatic and cycloplegic drugs: a review of ocular and systemic complications. Am J Optom Physiol Opt. 1982 Feb;59(2):162-77.
Results Reference
background
PubMed Identifier
15899444
Citation
Hofmeister EM, Kaupp SE, Schallhorn SC. Comparison of tropicamide and cyclopentolate for cycloplegic refractions in myopic adult refractive surgery patients. J Cataract Refract Surg. 2005 Apr;31(4):694-700. doi: 10.1016/j.jcrs.2004.10.068.
Results Reference
background
PubMed Identifier
8115124
Citation
Egashira SM, Kish LL, Twelker JD, Mutti DO, Zadnik K, Adams AJ. Comparison of cyclopentolate versus tropicamide cycloplegia in children. Optom Vis Sci. 1993 Dec;70(12):1019-26. doi: 10.1097/00006324-199312000-00005.
Results Reference
background
PubMed Identifier
21087952
Citation
Chen J, Xie A, Hou L, Su Y, Lu F, Thorn F. Cycloplegic and noncycloplegic refractions of Chinese neonatal infants. Invest Ophthalmol Vis Sci. 2011 Apr 14;52(5):2456-61. doi: 10.1167/iovs.10-5441.
Results Reference
background
PubMed Identifier
1263134
Citation
Salazar M, Shimada K, Patil PN. Iris pigmentation and atropine mydriasis. J Pharmacol Exp Ther. 1976 Apr;197(1):79-88.
Results Reference
background
PubMed Identifier
3228775
Citation
Nishizawa AR, Orton RB, Cadera W. Comparison of 0.5% cyclopentolate plus 0.5% tropicamide and 1% cyclopentolate alone for mydriasis of dark irides. Can J Ophthalmol. 1988 Dec;23(7):299-300.
Results Reference
background
PubMed Identifier
3777109
Citation
Lovasik JV. Pharmacokinetics of topically applied cyclopentolate HCl and tropicamide. Am J Optom Physiol Opt. 1986 Oct;63(10):787-803. doi: 10.1097/00006324-198610000-00001.
Results Reference
background
PubMed Identifier
2367089
Citation
Lovasik JV, Kergoat H. Time course of cycloplegia induced by a new phenylephrine-tropicamide combination drug. Optom Vis Sci. 1990 May;67(5):352-8. doi: 10.1097/00006324-199005000-00009.
Results Reference
background
PubMed Identifier
20035241
Citation
Anderson HA, Bertrand KC, Manny RE, Hu YS, Fern KD. Comparison of two drug combinations for dilating dark irides. Optom Vis Sci. 2010 Feb;87(2):120-4. doi: 10.1097/OPX.0b013e3181cc8da3.
Results Reference
background
PubMed Identifier
9715436
Citation
Lin LL, Shih YF, Hsiao CH, Su TC, Chen CJ, Hung PT. The cycloplegic effects of cyclopentolate and tropicamide on myopic children. J Ocul Pharmacol Ther. 1998 Aug;14(4):331-5. doi: 10.1089/jop.1998.14.331.
Results Reference
background
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A New More Efficient Cycloplegia Scheme
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