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

Completed

• Conditions: Cataract

• Registration Number: NCT06075459
• Lead Sponsor: Hanita Lenses

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.

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 Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-09-05
• Study Completion: 2023-09-05
• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Dr. Nano Eye Clinic; 🇦🇷 Buenos Aires, Argentina