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Post-op: Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens

Sponsor
Hanita Lenses (Industry)
Overall Status
Completed
CT.gov ID
NCT06075459
Collaborator
(none)
60
Enrollment
1
Location
6.2
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation.

The study will also evaluate the patient satisfaction of the implanted patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study Design:

    This study is an ambispective, single arm single center, open label study.

    Study Objectives:

    The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. The primary aim of this study is to evaluate the binocular defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.

    The second aim of this study is to evaluate the patient satisfaction 12 to 24 months post-operation.

    Study population:

    Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.

    Enrollment:

    The study will encompass a total of 60 eligible subjects implanted bilaterally (120 eyes) in total who will complete the protocol follow-up schedule.

    Duration of Subject participation:

    Duration of Subject participation is at most one month Completion of active enrolment is anticipated to last approximately 6 months. The primary aim will be finally evaluated when the last study subject has been recruited.

    Visits & Procedures Patients participating in the trial will attend a total of one visit (1 year follow up visit).

    Subjects will be selected from the physician's usual subjects' practice. All subjects meeting the inclusion criteria and having signed the Informed Consent Form will be evaluated by the Investigator according to the study protocol.

    1 year follow up visit: Pre-operation Visit: performed to check inclusion criteria, and to sign the informed consent.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
    Actual Study Start Date :
    Mar 1, 2023
    Actual Primary Completion Date :
    Sep 5, 2023
    Actual Study Completion Date :
    Sep 5, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Implanted patients with Intensity IOLs, 12-24 months previously

    Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.

    Outcome Measures

    Primary Outcome Measures

    1. The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. [21-24 months post operation]

      Performance of the IOL will be evaluated by assessing the defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.

    Secondary Outcome Measures

    1. The second aim of this study is to evaluate the patient satisfaction post-operation. [21-24 months post operation]

      Patient satisfaction will be evaluated by using Quality of Life (VH14) and satisfaction Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Implanted bilaterally using Hanita Intensity SL IOL

    • 12 to 24 months post implantation

    • Signed informed consent

    Exclusion Criteria:

    • Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Nano Eye Clinic Buenos Aires Argentina 1655 4 A

    Sponsors and Collaborators

    • Hanita Lenses

    Investigators

    • Principal Investigator: German Bianchi, MD, Dr. Nano Eye Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanita Lenses
    ClinicalTrials.gov Identifier:
    NCT06075459
    Other Study ID Numbers:
    • HTF-PM-AR
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 11, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hanita Lenses
    Cataract
    IOL
    Hanita Lenses
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Oct 11, 2023