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Status unknownNCT02177539Updated Jun 27, 2014

A New More Efficient Cycloplegia Scheme

A Phase 4 interventional study of Cyclopentolate and Cyclopentolate+tropicamide+phenylephrine in Refractive Errors, sponsored by Pontificia Universidad Catolica de Chile. Status unknown at 1 site in Chile. Open to participants aged 1 Year to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-27.

Sponsored by Pontificia Universidad Catolica de Chile · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Year to 10 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Refractive Errors

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Keywords

  • cycloplegia
  • refraction in children
  • cycloplegic agents
  • cycloplegic schemes
  • cyclopentolate
03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's planned enrollment of 30 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Children between 1 and 10 years

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Cyclopentolate

    Drug: Cyclopentolate · Drug: Cyclopentolate+tropicamide+phenylephrine

  • Experimental
    Cyclopentolate+tropicamide+phenylephrine

    Drug: Cyclopentolate · Drug: Cyclopentolate+tropicamide+phenylephrine

Interventions

  • DrugCyclopentolate

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

    Also known as: Cyclogyl

  • DrugCyclopentolate+tropicamide+phenylephrine

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

    Also known as: Cyclogyl, Mydfrin, Mydriacyl

06

What researchers measure

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.

    Time frame: average 18 days

Secondary outcomes

  1. Change in spherical refraction

    Change in spherical refraction between visit 1 and 2.

    Time frame: average 18 days

  2. Change in cylindrical refraction

    Change in cylindrical refraction between visit 1 and 2

    Time frame: average 18 days

  3. iris motility

    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 outcomes

  1. crying with the application

    does the child cry with both schemes?

    Time frame: average 18 days

  2. eyes color and cycloplegia

    there is a difference between the effectiveness of the schemes according to eye color?

    Time frame: average 18 days

07

Study locations

1 of 1 sites recruiting
  • Pontificia Universidad Catolica de Chile, Departamento de Oftalmología
    Santiago, Chile
    • Osvaldo H Berger, MD · Contact · oberger@uc.cl · +56966076844
    • Pablo Altschwager, MD · Sub investigator
    • Osvaldo H Berger, MD · Principal investigator
    • Cristian Salgado, MD · Principal investigator
    • Bernardita Alamos, MD · Sub investigator
    • Silvia Araneda, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 15498055 ↗
  • 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. PubMed 23986630 ↗
  • 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. PubMed 17534806 ↗
  • 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. PubMed 1513131 ↗
  • 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. PubMed 17325142 ↗
  • 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. PubMed 8414387 ↗
  • 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. PubMed 11349929 ↗
  • 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. PubMed 10082056 ↗
  • 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. PubMed 2034449 ↗
  • 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. PubMed 7039329 ↗
  • 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. PubMed 15899444 ↗
  • 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. PubMed 8115124 ↗
  • 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. PubMed 21087952 ↗
  • Salazar M, Shimada K, Patil PN. Iris pigmentation and atropine mydriasis. J Pharmacol Exp Ther. 1976 Apr;197(1):79-88. PubMed 1263134 ↗
  • 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. PubMed 3228775 ↗
  • 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. PubMed 3777109 ↗
  • 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. PubMed 2367089 ↗
  • 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. PubMed 20035241 ↗
  • 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. PubMed 9715436 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02177539
Lead sponsor
Pontificia Universidad Catolica de Chile
Responsible party
Sponsor
First posted
Jun 27, 2014
Start date
May 2014
Primary completion
Aug 2014 (estimated)
Completion
Sep 2014 (estimated)
Last update
Jun 27, 2014

Study contacts

Osvaldo H Berger, MD
Contact
oberger@uc.cl
+56966076844
Cristian Salgado
study chair · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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