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

• Conditions: Depth of cycloplegia; changes of astigmatism; recuperation from cycloplegia and mydriasis; MedDRA version: 12.1Level: LLTClassification code 10011719Term: Cycloplegia; MedDRA version: 12.1Level: PTClassification code 10011719Term: Cycloplegia

• Registration Number: EUCTR2010-021410-34-NL
• Lead Sponsor: Medical Centre Haaglanden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 423

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
Part III
•Emmetropia or myopia in SEQ values
•Isocoria and normal pupillary responses

* SEQ= sphere + cylinder:2
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
Part III
•Emmetropia or hypermetropia
•An-isocoria or abnormal pupillary responses

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified