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

Cataract Clinical Trial

— Post-op  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06075459
• Other study ID #: HTF-PM-AR
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: September 5, 2023

Study information

• Verified date: October 2023
• Source: Hanita Lenses
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
Argentina	Dr. Nano Eye Clinic	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hanita Lenses

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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