NCT06153745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

November 23, 2023

Last Update Submit

July 19, 2024

Conditions

Cataract in Child

Outcome Measures

Primary Outcomes (3)

  • Corrected Distance Visual Acuity

    Decimal

    3 months postoperatively

  • Corrected Intermediate Visual Acuity

    Decimal

    3 months postoperatively

  • Corrected Near Visual Acuity

    Decimal

    3 months postoperatively

Interventions

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

pediatric cataract surgery

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • monolateral cataract

You may not qualify if:

  • other ocular diseases
  • systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luca Buzzonetti

Roma, Italy

Location

Study Officials

  • Luca Buzzonetti

    Bambino Gesù Children's Hospital, Rome, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Ophthalmology Unit

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 1, 2023

Study Start

January 1, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

July 22, 2024

Record last verified: 2024-07

Locations

IT(1)