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Asferic Monofocal Intraocular Lens in Pediatric Patients

Sponsor
Bambino Gesù Hospital and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT06153745
Collaborator
(none)
13
Enrollment
1
Location
6.9
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the performance a new asferic monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: Tecnis Eyhance ICB00 intraocular lens (Johnson&Johnson Vision, Santa Ana, CA USA)

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).

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Asferic Monofocal Intraocular Lens With Higher Order Aspheric Optic in Pediatric Patients: Early Outcomes
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Jul 31, 2023
Actual Study Completion Date :
Jul 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Corrected Distance Visual Acuity [3 months postoperativeely]

    Decimal

  2. Corrected Intermediate Visual Acuity [3 months postoperatively]

    Decimal

  3. Corrected Near Visual Acuity [3 months postoperatively]

    Decimal

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 13 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • monolateral cataract
Exclusion Criteria:

  • other ocular diseases

  • sistemic diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bambino Gesù Children's Hospital Rome Italy

Sponsors and Collaborators

  • Bambino Gesù Hospital and Research Institute

Investigators

  • Principal Investigator: Luca Buzzonetti, MD, Bambino Gesù Children's Hospital, Rome, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT06153745
Other Study ID Numbers:
  • BG123
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Dec 1, 2023