Prospective, open, randomized, monocentric, two-armed, controlled clinical examination of phase 4 in cross-over-design for evaluation of the effect of tropicamide 0.5% eye drops vs. cyclopentolate 0.5% in cycloplegia for the objective refraction of the eye in 4- to 6 year old childre

Phase 4

Recruiting

Conditions: refraction errors, ametropia
H53.0
Amblyopia ex anopsia

Registration Number: DRKS00009985

Lead Sponsor: niversitätsklinikum Erlangenvertreten durch den Dekander Medizinischen Fakultät derFriedrich-Alexander-Universität Erlangen-Nürnberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Girl or boy aged =4 bis <7 years.
2. Indication for implementation of an objective retinoscopy.
3. Consent of the legal representative or representatives for participation of the minor in this clinical examination.
4. Consent of the minor to his/her participation in this clinical examination after age appropiate elucidation.

Exclusion Criteria

1. Hypersensitivity for tropicamide, cyclopentolate or another ingredient of the investigational dissection in the history.
2. Application of a medicament in the seven days before the visit.
3. Organic alteration of the to be examined eye.
4. down syndrom.
5. Brain injury in the history.
6. Epilepsy in the history.
7. Heart rate in in rest >120 beats per minute.
8. Severe organic disease in the history.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the grade of paralysis of accommodation (retinoscopy) after tropicamide versus cyclopentolate 30 minutes after application of tropicamide respectively second application of cyclopentolate in 4- to 6 year old children

Secondary Outcome Measures

Name	Time	Method
- Comparison of the measurement of astigmatism after tropicamide versus cyclopentolate 30 minutes after application of tropicamide respectively second application of cyclopentolate in 4- to 6 year old children.<br><br>- Comparison of the extent of mydriasis after tropicamide versus cyclopentolate 30 minutes after application of tropicamide respectively second application of cyclopentolate in 4- to 6 year old children.<br><br>- Comparison of safety and compatibility after tropicamide versus cyclopentolate in 4- to 6 year old children until 30 minutes after the examination and in positve case of SAE in the further follow-up.