Cataract in ChildNCT05241756
FLACS in Pediatric Patients Using FEMTO LDV-Z8
An observational study of Cataract in Child, run by Ziemer Ophthalmic Systems AG at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cataract in Child
- What is being tested?
- FLACS using FEMTO LDV-Z8
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jan 2022to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients of Antwerp University Hospital assigned to undergo a cataract surgery.
Who may be able to join
- 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
Who cannot join
- Eyes with microphthalmia of < 9 mm diameter white to white
- Hazy cornea
- Pregnancy; girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University and University Hospital Antwerp (UZA)
Edegem, Antwerp, 2650
Iske de Backer, 3 821 33 72 ext. +32, Iske.DeBacker@uza.be
Marie-José Tassignon, Professor
About this study
Official title: 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.
Read more
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
- Being tested
- FLACS using FEMTO LDV-Z8
- Keywords
- FLACS, Femto-LDV Z8, Pediatric, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLACS using FEMTO LDV-Z8Device
Performance of femtosecond laser-assisted capsulotomy in the anterior capsule.
| Study group | Role | What they receive |
|---|---|---|
| FLACS using FEMTO LDV-Z8 | Not described Receives: Device: FLACS using FEMTO LDV-Z8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intraoperative and postoperative adverse events
Number of intraoperative and postoperative adverse events
Measured: Up to 6 months
Secondary outcomes (2)
Aimed capsulotomy diameter
- Aimed diameter to be calculated using the Bochum formula
Measured: Done intraoperatively
Achieved capsulotomy diameter
- Achieved diameter will be assessed using a ring caliper (Morcher 4.8 external diameter), (US patent MJ Tassignon)
Measured: Done intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start25 Jan 2022
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract in ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziemer Ophthalmic Systems AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie-José Tassignon, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241756
- Sponsor's protocol ID
- CPFEM-0003-BE
- Status last verified
- Feb 2022
- First submitted
- 12 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femtosecond Laser-Assisted Cataract Surgery in Pediatric Patients, a Prospective Case Series
- ClinicalTrials.gov ID
- NCT05241756
- Acronym / sponsor ID
- CPFEM-0003-BE
- Conditions
- Cataract in Child
- Keywords
- FLACS, Femto-LDV Z8, Pediatric, Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ziemer Ophthalmic Systems AGIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLACS using FEMTO LDV-Z8 | – | Device: FLACS using FEMTO LDV-Z8 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients of Antwerp University Hospital assigned to undergo a cataract surgery.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Eyes with microphthalmia of < 9 mm diameter white to white
- Hazy cornea
- Pregnancy; girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLACS using FEMTO LDV-Z8Performance of femtosecond laser-assisted capsulotomy in the anterior capsule. | Device | FLACS using FEMTO LDV-Z8 |
Primary outcome
Number of intraoperative and postoperative adverse events
Time frame: Up to 6 months
Number of intraoperative and postoperative adverse events
2 secondary outcomes
Aimed capsulotomy diameter
Time frame: Done intraoperatively
Achieved capsulotomy diameter
Time frame: Done intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Cataract in Child
Recruiting
Guangke Lenses in Congenital Cataract
Congenital Cataract
Active, not recruitingObservational study
Long-term Visual and Refractive Outcomes After Traumatic Cataract Surgery in Children
Traumatic Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-José Tassignon, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract in Child, run by Ziemer Ophthalmic Systems AG at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Grossenbacher, MD, PhD (323327085 ext. +41, olga.grossenbacher@ziemergroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intraoperative and postoperative adverse events (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.