A double blind randomized study on the effectiveness of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in dark irided hypermetropic childre
Completed
- Conditions
- Eye strenght. Refraction10047518
- Registration Number
- NL-OMON30949
- Lead Sponsor
- Medisch Centrum Haaglanden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
Healthy; not suffering from syndromes or diseases, 3 to 6 years (not attending group three of 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.
Exclusion Criteria
All children not possesing the inclusioncriteria (D4a)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome parameter is the refractive outcome. Differences will be<br /><br>considered statistical significant if p<0.05. A difference in refractive<br /><br>outcome of > 0.25 D will be considered clinical significant.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are amount of cycloplegia and time to reach optimal<br /><br>refractive outcome and amount of cycloplegia. Differences will be considered<br /><br>statistical significant if p<0.05. A difference in amount of accommodation of ><br /><br>0.25 D and a difference in time to optimal refractive outcome and/or maximum<br /><br>cycloplegia of >10 minutes will be considered clinical significant.</p><br>