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Clinical Trials/NL-OMON34025
NL-OMON34025
Completed
Phase 3

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

Medisch Centrum Haaglanden0 sites419 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Medisch Centrum Haaglanden
Enrollment
419
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • Healthy, light to very dark irided, 7 to 13 years old volunteers, visiting group 4 to 8 of the Dutch primary school system. In addition to be included in survey I and II, children should be hypermetropic; whether or not wearing glasses, with normal accommodation, sufficient reading capabilities and a best corrected visual acuity for distance of \>\<\=0\.7 and near of \>\<\=1\.0\. To be included in survey III children should be emmetropic or myopic, have pupils that are equal in size and react normally.

Exclusion Criteria

  • Physical illness, aged \<7 and \>13 year, attending group 3 of the Dutch school system or attending secondary school. For survey I and II refractive errors \< \+0\.50D with or without glasses, insufficient accommodation, insufficient reading capabilities, best corrected distance visual acuity of \< 0\.7 and near visual acuity of \<1\.0\. For survey III having hypermetropia, unequal pupil sizes or abnormal pupillary reactions.

Outcomes

Primary Outcomes

Not specified

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