ClinicalTrials.gg
CompletedNCT06153745Updated Jul 22, 2024

Aspheric Monofocal Intraocular Lens in Pediatric Patients

An observational study in Cataract in Child, sponsored by Luca Buzzonetti. Completed at 1 site in Italy. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Luca Buzzonetti · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
13
Ages
6 Years to 13 Years
Sex
All
01

Study 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 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).

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Conditions studied

  • Cataract in Child
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In context

Lead sponsor

Luca Buzzonetti is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 13 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • monolateral cataract

Exclusion criteria

Exclusion Criteria:

  • other ocular diseases
  • systemic diseases
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
13 participants (actual)
Patient registry
No

Interventions

  • DeviceTecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, California USA)

    pediatric cataract surgery

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What researchers measure

Primary outcomes

  1. Corrected Distance Visual Acuity

    Decimal

    Time frame: 3 months postoperatively

  2. Corrected Intermediate Visual Acuity

    Decimal

    Time frame: 3 months postoperatively

  3. Corrected Near Visual Acuity

    Decimal

    Time frame: 3 months postoperatively

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Study locations

1 site
  • Luca Buzzonetti
    Roma, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06153745
Lead sponsor
Luca Buzzonetti
Responsible party
Luca Buzzonetti (Head of Ophthalmology Unit, Bambino Gesù Hospital and Research Institute) — Sponsor-investigator
First posted
Dec 1, 2023
Start date
Jan 1, 2023
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Jul 22, 2024

Study contacts

Luca Buzzonetti
principal investigator · Bambino Gesù Children's Hospital, Rome, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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