Clinical trial NCT06075459: Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
Official title: Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Cataract
IOL
Hanita Lenses
Lead sponsor: Hanita Lenses
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.
timeFrame: 21-24 months post operation
Secondary outcomes:
measure: The second aim of this study is to evaluate the patient satisfaction post-operation.
timeFrame: 21-24 months post operation
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Dr. Nano Eye Clinic
Study officials:
affiliation: Dr. Nano Eye Clinic
name: German Bianchi, MD
role: PRINCIPAL_INVESTIGATOR
References: