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

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.

Study Overview

• Status: Completed
• Conditions: Cataract

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1655 4 A
    • Dr. Nano Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.	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.	21-24 months post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The second aim of this study is to evaluate the patient satisfaction post-operation.	Patient satisfaction will be evaluated by using Quality of Life (VH14) and satisfaction Questionnaire	21-24 months post operation

Collaborators and Investigators

• Sponsor: Hanita Lenses
• Investigators: Principal Investigator: German Bianchi, MD, Dr. Nano Eye Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): September 5, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cataract; IOL; Hanita Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: HTF-PM-AR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No