Een dubbelblind gerandomiseerd onderzoek naar de doelmatigheid van cyclopentolaat 1% en cyclopentolaat 1% met tropicamide 1% bij kinderen. Afkorting: Doelmatigheid van cycloplegica.
- Conditions
- cycloplegia, residual accommodation, mydriasis, astigmatism, pupillary reaction to light, recupertion time.
- Registration Number
- NL-OMON21701
- Lead Sponsor
- RvBMedical Centre HaaglandenPostbus 4322501 CK The HagueThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 419
Inclusion Criteria
General:
1. Requiring an objective refraction because of standard departmental protocol;
Exclusion Criteria
General:
1. Physical illness;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome parameters are residual accommodation; e.g. depth of cycloplegia (survey I) and recuperation time of ciliary paralysis (survey II) and sphincter paralysis (survey III). Differences will be considered statistical significant if p<0.05. A difference in residual accommodation of > 0.50 D, a difference in recuperation time of > 2 hours of cycloplegia and pupillary functions, will be considered clinical significant.
- Secondary Outcome Measures
Name Time Method 1. Time to maximum cycloplegia;<br /><br>2. Time of stability of (maximum) cycloplegia;<br /><br>3. Changes in astigmatism;<br /><br>4. Mydriasis ;<br /><br>5. Pupillary reaction to light.<br><br /><br /><br>Differences will be considered statistical significant if p<0.05. A difference in time to maximum cycloplegia of > 10 minutes, a difference in stability time of > 10 minutes, and a change of > 0.50 D cylinder or a change of >5° in cylindrical axi,s a difference of >0.5 mm of pupil diameter increase, a difference of 1 category pupil reaction to light in the median will be considered clinical significant.