Aspheric Monofocal Intraocular Lens in Pediatric Patients

NCT ID: NCT06153745

Last Updated: 2024-07-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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Cataract in Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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

pediatric cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* monolateral cataract

Exclusion Criteria

* other ocular diseases
* systemic diseases
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luca Buzzonetti

OTHER

Sponsor Role lead

Responsible Party

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Luca Buzzonetti

Head of Ophthalmology Unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Luca Buzzonetti

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Children's Hospital, Rome, Italy

Locations

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Luca Buzzonetti

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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BG123

Identifier Type: -

Identifier Source: org_study_id

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