Aspheric Monofocal Intraocular Lens in Pediatric Patients | NCT06153745

Studies
Aspheric Monofocal Intraocular Lens in Pediatric Patients

NCT06153745

Sponsor

Luca Buzzonetti

Status

Completed

Last Update Posted

Jul 22, 2024Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Cataract in Child

Interventions

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

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jul 31, 2023Actual

Completion Date

Jul 31, 2023Actual

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Nov 23, 2023

First Posted Date

Dec 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2024

Last Update Posted Date

Jul 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luca Buzzonetti, Head of Ophthalmology Unit, Bambino Gesù Hospital and Research InstituteSponsor-Investigator

Lead Sponsor

Luca BuzzonettiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, California USA)	Device	pediatric cataract surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corrected Distance Visual Acuity	Decimal	3 months postoperatively
Corrected Intermediate Visual Acuity	Decimal	3 months postoperatively
Corrected Near Visual Acuity	Decimal	3 months postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

monolateral cataract

Exclusion Criteria:

other ocular diseases
systemic diseases

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luca Buzzonetti	Bambino Gesù Children's Hospital, Rome, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Luca Buzzonetti		Roma			Italy