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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclopentolate | Active Comparator |
| |
| Cyclopentolate+tropicamide+phenylephrine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclopentolate | Drug | Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spherical refraction | Change in spherical refraction between visit 1 and 2. | average 18 days |
| Change in cylindrical refraction | Change in cylindrical refraction between visit 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| crying with the application | does the child cry with both schemes? | average 18 days |
| eyes color and cycloplegia | there is a difference between the effectiveness of the schemes according to eye color? |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osvaldo H Berger, MD | Contact | +56966076844 | oberger@uc.cl |
| Name | Affiliation | Role |
|---|---|---|
| Cristian Salgado | Pontificia Universidad Catolica de Chile | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Catolica de Chile, Departamento de OftalmologÃa | Recruiting | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15498055 | Background | 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. | |
| 23986630 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2015 | |
| Reset | Dec 7, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2015 | Dec 7, 2015 |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003519 | Cyclopentolate |
| D010109 | Oxymetazoline |
| D014331 | Tropicamide |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Cyclopentolate+tropicamide+phenylephrine | Drug | New scheme. All drugs together and wait 30 minutes for retinoscopy |
|
|
| average 18 days |
| iris motility | both schemes are effective in cycloplegia ? In visit 1 and 2 the iris motility after the cyclopegic schemes will be evaluated | average 18 days |
| average 18 days |
| 17534806 | 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. |
| 1513131 | 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. |
| 17325142 | 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. |
| 8414387 | 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. |
| 11349929 | 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. |
| 10082056 | 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. |
| 2034449 | 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. |
| 7039329 | 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. |
| 15899444 | 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. |
| 8115124 | 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. |
| 21087952 | 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. |
| 1263134 | Background | Salazar M, Shimada K, Patil PN. Iris pigmentation and atropine mydriasis. J Pharmacol Exp Ther. 1976 Apr;197(1):79-88. |
| 3228775 | 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. |
| 3777109 | 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. |
| 2367089 | 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. |
| 20035241 | 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. |
| 9715436 | 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. |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |