Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
12 participants
OBSERVATIONAL
2022-01-25
2023-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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FLACS using FEMTO LDV-Z8
FLACS using FEMTO LDV-Z8
Performance of femtosecond laser-assisted capsulotomy in the anterior capsule.
Interventions
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FLACS using FEMTO LDV-Z8
Performance of femtosecond laser-assisted capsulotomy in the anterior capsule.
Eligibility Criteria
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Inclusion Criteria
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
2. Hazy cornea
3. Pregnancy; girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion.
18 Years
ALL
No
Sponsors
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Ziemer Ophthalmic Systems AG
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-José Tassignon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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Antwerp University and University Hospital Antwerp (UZA)
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CPFEM-0003-BE
Identifier Type: -
Identifier Source: org_study_id
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