A New More Efficient Cycloplegia Scheme

NCT02177539 | Unknown Phase 4

• 1 other identifier: 12-344
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Refractive Errors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  average 18 days

Secondary Outcomes (3)

• Change in spherical refraction

  average 18 days

• Change in cylindrical refraction

  average 18 days

• iris motility

  average 18 days

Other Outcomes (2)

• crying with the application

  average 18 days

• eyes color and cycloplegia

  average 18 days

Study Arms (2)

Cyclopentolate

ACTIVE COMPARATOR

Drug: Cyclopentolate; Drug: Cyclopentolate+tropicamide+phenylephrine

Cyclopentolate+tropicamide+phenylephrine

EXPERIMENTAL

Drug: Cyclopentolate; Drug: Cyclopentolate+tropicamide+phenylephrine

Interventions

Cyclopentolate DRUG

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

Also known as: Cyclogyl

Cyclopentolate; Cyclopentolate+tropicamide+phenylephrine

Cyclopentolate+tropicamide+phenylephrine DRUG

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

Also known as: Cyclogyl, Mydfrin, Mydriacyl

Cyclopentolate; Cyclopentolate+tropicamide+phenylephrine

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between 1 and 10 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Catolica de Chile, Departamento de Oftalmología

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (19)

• 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.

  PMID: 15498055 BACKGROUND

• 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.

  PMID: 23986630 BACKGROUND

• 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.

  PMID: 17534806 BACKGROUND

• 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.

  PMID: 1513131 BACKGROUND

• 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.

  PMID: 17325142 BACKGROUND

• 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.

  PMID: 8414387 BACKGROUND

• 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.

  PMID: 11349929 BACKGROUND

• 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.

  PMID: 10082056 BACKGROUND

• 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.

  PMID: 2034449 BACKGROUND

• 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.

  PMID: 7039329 BACKGROUND

• 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.

  PMID: 15899444 BACKGROUND

• 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.

  PMID: 8115124 BACKGROUND

• 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.

  PMID: 21087952 BACKGROUND

• Salazar M, Shimada K, Patil PN. Iris pigmentation and atropine mydriasis. J Pharmacol Exp Ther. 1976 Apr;197(1):79-88.

  PMID: 1263134 BACKGROUND

• 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.

  PMID: 3228775 BACKGROUND

• 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.

  PMID: 3777109 BACKGROUND

• 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.

  PMID: 2367089 BACKGROUND

• 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.

  PMID: 20035241 BACKGROUND

• 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.

  PMID: 9715436 BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Interventions

Cyclopentolate; Oxymetazoline; Tropicamide

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines

Study Officials

• Cristian Salgado

  Pontificia Universidad Catolica de Chile

  STUDY CHAIR

Central Study Contacts

Osvaldo H Berger, MD

CONTACT

+56966076844; oberger@uc.cl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 27, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 27, 2014

Record last verified: 2014-06

Locations

CL (1)