MyKid-study: a study to examine the effect and safety of an injection of Mydrane® into the eye of children who will undergo cataract surgery
Phase 1
- Conditions
- pediatric cataractTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2023-504173-21-00
- Lead Sponsor
- Antwerp University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Children aged 8 weeks to 17 years old who are scheduled for surgical cataract repair of one or both eyes
Exclusion Criteria
Patients with a reported allergy for one of the components of Mydrane®, Patients younger than 8 weeks, patients who previously had cataract surgery of one eye within this study and receive surgery of the contralateral eye on a different day, Patients who are pregnant. Girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion
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