FLACS in Pediatric Patients Using FEMTO LDV-Z8

Femtosecond Laser-Assisted Cataract Surgery in Pediatric Patients, a Prospective Case Series

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract in Child
• Intervention / Treatment: Device: FLACS using FEMTO LDV-Z8

• Study Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

• Study Contact: Name: Olga Grossenbacher, MD, PhD; Phone Number: +41 323327085; Email: olga.grossenbacher@ziemergroup.com

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University and University Hospital Antwerp (UZA)
      • Contact: Iske de Backer; Phone Number: +32 3 821 33 72; Email: Iske.DeBacker@uza.be
      • Principal Investigator: Marie-José Tassignon, Professor
      • Sub-Investigator: Luc van Os, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients of Antwerp University Hospital assigned to undergo a cataract surgery.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FLACS using FEMTO LDV-Z8	Device: FLACS using FEMTO LDV-Z8; Performance of femtosecond laser-assisted capsulotomy in the anterior capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intraoperative and postoperative adverse events	Number of intraoperative and postoperative adverse events	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aimed capsulotomy diameter	- Aimed diameter to be calculated using the Bochum formula	Done intraoperatively
Achieved capsulotomy diameter	- Achieved diameter will be assessed using a ring caliper (Morcher 4.8 external diameter), (US patent MJ Tassignon)	Done intraoperatively

Collaborators and Investigators

• Sponsor: Ziemer Ophthalmic Systems AG
• Investigators: Principal Investigator: Marie-José Tassignon, MD, PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pediatric; Cataract; FLACS; Femto-LDV Z8
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CPFEM-0003-BE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No