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Aspheric Monofocal Intraocular Lens in Pediatric Patients

Aspheric Monofocal Intraocular Lens With Higher Order Aspheric Optic in Pediatric Patients: Early Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06153745
Enrollment
13
Registered
2023-12-01
Start date
2023-01-01
Completion date
2023-07-31
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract in Child

Brief 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.

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).

Interventions

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

pediatric cataract surgery

Sponsors

Luca Buzzonetti
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years

Inclusion criteria

* monolateral cataract

Exclusion criteria

* other ocular diseases * systemic diseases

Design outcomes

Primary

MeasureTime frameDescription
Corrected Distance Visual Acuity3 months postoperativelyDecimal
Corrected Intermediate Visual Acuity3 months postoperativelyDecimal
Corrected Near Visual Acuity3 months postoperativelyDecimal

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026