a double blind randomized study on the effectiveness of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in dark irided hypermetropic children - effectiveness of cycloplegics
- Conditions
- refraction of the eye/ refractive state of the eyeMedDRA version: 9.1Level: LLTClassification code 10038264Term: Refraction disorder
- Registration Number
- EUCTR2007-003483-22-NL
- Lead Sponsor
- Medisch Centrum Haaglanden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 45
Healthy; not suffering from syndromes or diseases, 3 to 6 years (not attending groups three of the Dutch primary school system) old very dark irided hypermetropic children, possesing good accommodation, with no glasses prior or who did not wear their hypermetropic glasses since at least 4 weeks and able to fixate with each eye.
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
Not healthy, e.g. suffering from syndromes or diseases, very dark irided hypermetorpic children, possessing good accommodation, aged 3 to 6 years. Or healthy very dark irided hypermetropic children, aged 3 to 6 years but visiting the third year of Dutch primary school. Hypoaccommodation. Wearing glasses. Not able to fixate with each eye.
E.g. children not possessing the inclusioncriteria mentioned in E.3
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method