Status:
UNKNOWN
FLACS in Pediatric Patients Using FEMTO LDV-Z8
Lead Sponsor:
Ziemer Ophthalmic Systems AG
Conditions:
Cataract in Child
Eligibility:
All Genders
Up to 18 years
Brief Summary
This study is a single center prospective observational case series. The framework of this clinical investigation is post market clinical follow up of pediatric FLACS using the Femto LDV Z8. The inten...
Eligibility Criteria
Inclusion
- Age \< 18 years at the time of surgery
- In case of bilateral cataract, only one eye will be included in the study
- Informed consent of the legal representative of the patient (and as applicable, the patient) documented per signature
- Planned cataract surgery
- Accurate baseline biometric measurements
- Assessed medical status
- Full pupil dilatation is achieved using Cyclopentolate eye drops
Exclusion
- Eyes with microphthalmia of \< 9 mm diameter white to white
- Hazy cornea
- Pregnancy; girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05241756
Start Date
January 25 2022
End Date
January 1 2023
Last Update
February 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Antwerp University and University Hospital Antwerp (UZA)
Edegem, Antwerp, Belgium, 2650