A New More Efficient Cycloplegia Scheme

Refractive Errors Clinical Trial

Official title:

A New More Efficient Cycloplegia Scheme

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02177539
• Other study ID #: 12-344
• Status: Unknown status
• Phase: Phase 4
• First received: May 27, 2014
• Last updated: June 25, 2014
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: June 2014
• Source: Pontificia Universidad Catolica de Chile
• Contact: Osvaldo H Berger, MD
• Phone: +56966076844
• Email: oberger[@]uc.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Drug:
• Cyclopentolate
Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.
• Cyclopentolate+tropicamide+phenylephrine
New scheme. All drugs together and wait 30 minutes for retinoscopy

Locations

Country	Name	City	State
Chile	Pontificia Universidad Catolica de Chile, Departamento de Oftalmología	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (19)

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. German. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Lovasik JV. Pharmacokinetics of topically applied cyclopentolate HCl and tropicamide. Am J Optom Physiol Opt. 1986 Oct;63(10):787-803. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

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

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	crying with the application	does the child cry with both schemes?	average 18 days
Other	eyes color and cycloplegia	there is a difference between the effectiveness of the schemes according to eye color?	average 18 days
Primary	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	Change in spherical refraction	Change in spherical refraction between visit 1 and 2.	average 18 days
Secondary	Change in cylindrical refraction	Change in cylindrical refraction between visit 1 and 2	average 18 days
Secondary	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