Clinical trial NCT05241756: FLACS in Pediatric Patients Using FEMTO LDV-Z8
Official title: Femtosecond Laser-Assisted Cataract Surgery in Pediatric Patients, a Prospective Case Series
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract in Child
Keywords: FLACS
Femto-LDV Z8
Pediatric
Cataract
Lead sponsor: Ziemer Ophthalmic Systems AG
Sponsor class: INDUSTRY
First posted: 2022-02-16
Enrollment: 12
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients of Antwerp University Hospital assigned to undergo a cataract surgery.

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 intention is to investigate and supervise aspects particular to the pediatric use, and there is hence no alternative patient population.

Primary outcome Related adverse events at the time of surgery, ophthalmic adverse events at 1 week, 1 month, 6 months.

Secondary outcome Achieved vs aimed capsulotomy diameter

* Aimed diameter to be calculated using the Bochum formula
* Achieved diameter will be assessed using a ring caliper (Morcher 4.8 external diameter), (US patent MJ Tassignon)

During the recruitment period, the legal representatives of all patients (and when applicable the patients) at the study site who are eligible for pediatric cataract surgery and fulfilling the eligibility criteria will be informed about the study and offered participation. The aim is to include 12 participants during the recruitment period of 6 months. Inclusion criteria are on purpose chosen very broad, in order to collect data from all types of pediatric cataract surgeries.The majority of the participants will be very young children, who cannot be involved in the informed consent procedure. Participants will nevertheless receive the patient information in a way adapted to their age and mental maturity, from investigators or members of the investigating team who are experienced in working with children. The study procedure is cataract surgery performed with the FEMTO LDV Z8 femtosecond laser. In this clinical investigation the CE marked products (the Femto LDV™ femtosecond laser and the FEMTO LDV™ Surgical Laser Procedure Packs for Cataract Surgery) are used without deviations from the intended use and indication for use. Intraoperatively the achieved capsulotomy diameter will assessed using a ring caliper (Morcher 4.8 external diameter) and compared with the aimed diameter calculated using the Bochum formula. Patients will return for follow-up visits at 1 week, 1 month, 6 months after the surgery.


Eligibility criteria: Inclusion Criteria:

1. Age \< 18 years at the time of surgery
2. In case of bilateral cataract, only one eye will be included in the study
3. Informed consent of the legal representative of the patient (and as applicable, the patient) documented per signature
4. Planned cataract surgery
5. Accurate baseline biometric measurements
6. Assessed medical status
7. Full pupil dilatation is achieved using Cyclopentolate eye drops

Exclusion Criteria:

1. Eyes with microphthalmia of \< 9 mm diameter white to white
2. Hazy cornea
3. Pregnancy; girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion.

Primary outcomes:
measure: Number of intraoperative and postoperative adverse events
timeFrame: Up to 6 months
Secondary outcomes:
measure: Aimed capsulotomy diameter
timeFrame: Done intraoperatively
measure: Achieved capsulotomy diameter
timeFrame: Done intraoperatively
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University and University Hospital Antwerp (UZA)
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Marie-José Tassignon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: