FLACS in Pediatric Patients Using FEMTO LDV-Z8

NCT05241756 | Unknown

• 1 other identifier: CPFEM-0003-BE
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract in Child

Keywords

FLACS; Femto-LDV Z8; Pediatric; Cataract

Outcome Measures

Primary Outcomes (1)

• Number of intraoperative and postoperative adverse events

  Number of intraoperative and postoperative adverse events

  Up to 6 months

Secondary Outcomes (2)

• Aimed capsulotomy diameter

  Done intraoperatively

• Achieved capsulotomy diameter

  Done intraoperatively

Study Arms (1)

FLACS using FEMTO LDV-Z8

Device: FLACS using FEMTO LDV-Z8

Interventions

FLACS using FEMTO LDV-Z8 DEVICE

Performance of femtosecond laser-assisted capsulotomy in the anterior capsule.

FLACS using FEMTO LDV-Z8

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Eyes with microphthalmia of \< 9 mm diameter white to white
• Hazy cornea

Sponsors & Collaborators

• Ziemer Ophthalmic Systems AG: lead

Study Sites (1)

Antwerp University and University Hospital Antwerp (UZA)

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Marie-José Tassignon, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Grossenbacher, MD, PhD

CONTACT

323327085; olga.grossenbacher@ziemergroup.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 16, 2022
• Study Start: January 25, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)