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Refractive ErrorsPhase 4NCT02177539

A New More Efficient Cycloplegia Scheme

A Phase 4 study testing Cyclopentolate and Cyclopentolate+tropicamide+phenylephrine in people with Refractive Errors, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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) Read more about this study

Who is it for?
Ages 1 year to 10 yearsHealthy volunteers can take part
Conditions the study is for
Refractive Errors
What is being tested?
Cyclopentolate and Cyclopentolate+tropicamide+phenylephrine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChile
Study dates
May 2014to Sep 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children between 1 and 10 years

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Osvaldo H Berger, MD contact

+56966076844

oberger@uc.cl

Chile1 site, 1 recruiting

  • Pontificia Universidad Catolica de Chile, Departamento de Oftalmología

    Santiago, Santiago Metropolitan

    Osvaldo H Berger, MD, +56966076844, oberger@uc.cl

    Pablo Altschwager, MD

    Recruiting

Other trials in Chile

About this study

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)

Being tested
Cyclopentolate, Cyclopentolate+tropicamide+phenylephrine
Keywords
cycloplegia, refraction in children, cycloplegic agents, cycloplegic schemes, cyclopentolate
Medical subject headings
Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclopentolateDrug

    Also called Cyclogyl

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

  • Cyclopentolate+tropicamide+phenylephrineDrug

    Also called Cyclogyl, Mydfrin, Mydriacyl

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

Study groups in NCT02177539
Study groupRoleWhat they receive
CyclopentolateActive comparatorNot described
Receives: Drug: Cyclopentolate; Drug: Cyclopentolate+tropicamide+phenylephrine
Cyclopentolate+tropicamide+phenylephrineExperimentalNot described
Receives: Drug: Cyclopentolate; Drug: Cyclopentolate+tropicamide+phenylephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: average 18 days

Secondary outcomes (3)

  1. Change in spherical refraction

    Change in spherical refraction between visit 1 and 2.

    Measured: average 18 days

  2. Change in cylindrical refraction

    Change in cylindrical refraction between visit 1 and 2

    Measured: 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

    Measured: average 18 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionAug 2014 (estimated)
  4. Study completionSep 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02177539
Sponsor's protocol ID
12-344
Status last verified
Jun 2014
First submitted
27 May 2014
Last updated
27 Jun 2014
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cyclopentolate and Cyclopentolate+tropicamide+phenylephrine in people with Refractive Errors, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Osvaldo H Berger, MD (+56966076844, oberger@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Spherical equivalent (time frame: average 18 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02177539, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.

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