FLACS in Pediatric Patients Using FEMTO LDV-Z8

• Sponsor: Ziemer Ophthalmic Systems AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05241756
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Anticipated Duration (Months): 11.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract in Child	Device: FLACS using FEMTO LDV-Z8

Study Design

• Study Type: Observational
• Anticipated Enrollment: 12 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Femtosecond Laser-Assisted Cataract Surgery in Pediatric Patients, a Prospective Case Series
• Actual Study Start Date: Jan 25, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of intraoperative and postoperative adverse events [Up to 6 months]

   Number of intraoperative and postoperative adverse events

Secondary Outcome Measures

1. Aimed capsulotomy diameter [Done intraoperatively]

   - Aimed diameter to be calculated using the Bochum formula

2. Achieved capsulotomy diameter [Done intraoperatively]

   - Achieved diameter will be assessed using a ring caliper (Morcher 4.8 external diameter), (US patent MJ Tassignon)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antwerp University and University Hospital Antwerp (UZA)	Edegem	Antwerp	Belgium	2650

Sponsors and Collaborators

• Ziemer Ophthalmic Systems AG

Investigators

• Principal Investigator: Marie-José Tassignon, MD, PhD, University Hospital, Antwerp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziemer Ophthalmic Systems AG
• ClinicalTrials.gov Identifier: NCT05241756
• Other Study ID Numbers: CPFEM-0003-BE
• First Posted: Feb 16, 2022
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ziemer Ophthalmic Systems AG: FLACS; Femto-LDV Z8; Pediatric; Cataract
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Feb 16, 2022