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Clinical Trials/EUCTR2010-021410-34-NL
EUCTR2010-021410-34-NL
Active, not recruiting
Not Applicable

A double blind randomized study on the efficacy of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in children - Efficacy of cycloplegics

Medical Centre Haaglanden0 sites423 target enrollmentJune 24, 2010
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ConditionsDepth of cycloplegiachanges of astigmatismrecuperation from cycloplegia and mydriasisMedDRA version: 12.1Level: LLTClassification code 10011719Term: CycloplegiaMedDRA version: 12.1Level: PTClassification code 10011719Term: Cycloplegia
Drugscyclopentolaat hydrochloride 1% 10mg/mltropicamide 1%; 10 mg/ml

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depth of cycloplegia
Sponsor
Medical Centre Haaglanden
Enrollment
423
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 24, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medical Centre Haaglanden

Eligibility Criteria

Inclusion Criteria

  • •Patient is considered for the study when:
  • •Good general health
  • •Age 7 to 13 years
  • •oGroup 4 \- 8 of the Dutch primairy school system
  • •Part I and II
  • •Hypermetropia; e.g. \> 0\. 50 diopters in spherical equivalence (SEQ) values\*
  • •Good accommodation; e.q. \> 10 diopters with dynamic retinoscopy
  • •Sufficient reading capabilities
  • •Best corrected distance visual acuity (BCDVA) of \> 0\.7 in each eye
  • •Best corrected near visual acuity (BCNVA) of \> 1\.0 in each eye

Exclusion Criteria

  • •Not healthy
  • •Aged \<6 and \>13 year
  • •Attending group 3 of the Dutch school system
  • •Attending secondary school
  • •Part I and II
  • •Refractive errors \< \+0\.50
  • •Best corrected visual acuity of \< 0\.7 in one or both eye’s
  • •Insufficient reading capabilities
  • •Insufficient accommodation
  • •Emmetropia or hypermetropia

Outcomes

Primary Outcomes

Not specified

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