Cataract in ChildNCT06153745
Aspheric Monofocal Intraocular Lens in Pediatric Patients
An observational study of Cataract in Child, run by Luca Buzzonetti at 1 site in Italy.
Trial summary
To evaluate the performance a new aspheric monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Cataract in Child
- What is being tested?
- Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, California USA)
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 31 Jul 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 6 to 13 years
- All sexes
- Child
Study population: primary care clinic
Who may be able to join
- monolateral cataract
Who cannot join
- other ocular diseases
- systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aspheric Monofocal Intraocular Lens With Higher Order Aspheric Optic in Pediatric Patients: Early Outcomes
To evaluate the performance a new aspheric monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.
Read the detailed description
thirteen patients (mean age 7.6±3.8 years) who underwent cataract surgery and simultaneous implantation of the Tecnis Eyhance ICB00 IOL were evaluated. Visual acuity was assessed three months after surgery for distance (CDVA), intermediate (CIVA) and near visual acuity (CNVA).
- Conditions
- Cataract in Child
- Being tested
- Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, California USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, California USA)Device
pediatric cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected Distance Visual Acuity
Decimal
Measured: 3 months postoperatively
Corrected Intermediate Visual Acuity
Decimal
Measured: 3 months postoperatively
Corrected Near Visual Acuity
Decimal
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luca Buzzonetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luca Buzzonetti, Bambino Gesù Hospital and Research Institute
- Investigators
- Luca Buzzonetti, Principal investigator, Bambino Gesù Children's Hospital, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153745
- Sponsor's protocol ID
- BG123
- Status last verified
- Jul 2024
- First submitted
- 23 Nov 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspheric Monofocal Intraocular Lens With Higher Order Aspheric Optic in Pediatric Patients: Early Outcomes
- ClinicalTrials.gov ID
- NCT06153745
- Acronym / sponsor ID
- BG123
- Conditions
- Cataract in Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Luca BuzzonettiUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 1 Dec 2023 (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.
To evaluate the performance a new aspheric monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.
Detailed description
thirteen patients (mean age 7.6±3.8 years) who underwent cataract surgery and simultaneous implantation of the Tecnis Eyhance ICB00 IOL were evaluated. Visual acuity was assessed three months after surgery for distance (CDVA), intermediate (CIVA) and near visual acuity (CNVA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Age groups
- Child
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- monolateral cataract
Key exclusion criteria (2 listed)
- other ocular diseases
- systemic diseases
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 |
|---|---|---|
| Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, California USA)pediatric cataract surgery | Device | – |
Primary outcome
Corrected Distance Visual Acuity
Time frame: 3 months postoperatively
Decimal
Corrected Intermediate Visual Acuity
Time frame: 3 months postoperatively
Decimal
Corrected Near Visual Acuity
Time frame: 3 months postoperatively
Decimal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
Luca Buzzonetti principal investigator
Bambino Gesù Children's Hospital, Rome, Italy
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 Luca Buzzonetti at 1 site in Italy.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 22 Jul 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected Distance Visual Acuity (time frame: 3 months postoperatively). The study lists 3 primary outcomes in all. 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 22 Jul 2024.