Data Collection After Intensity IOL Implantations

Intensity Lenses Post Operation Standard of Care Visits - Data Collection.

Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Intra Ocular Lens

Detailed Description

Different multifocal intraocular lens (MIOL) designs have been used for more than 25 years1. Unlike conventional mono focal intraocular lenses (IOLs), which bend light to a single focus point on the retina, MIOLs are designed to help patients to see at varying distances using different points of focus2. MIOLs used in clinical practice were either refractive initially, or later diffractive in their optical design. Refractive MIOLs incorporate a lens optic with different optical powers in different parts of the lens, while diffractive MIOLs use diffractive steps on the lens to distribute light rays into two or more principal foci. Irrespective of the design type, however, all MIOLs involve some form of optical compromise and a process of neuroadaptation for the patient.

Intensity SL intraocular lenses (IOLs) represent the latest in premium lens technology. Intensity SL lenses provide clear vision at all distances - from near to far - thus offering the best chance of true spectacle independence.

Despite the promising results obtained with the latest generation of MIOLs, many surgeons remain reluctant to implant these lenses. Visual symptoms such as glare and haloes, reduced contrast sensitivity and night vision problems are all known complications of multifocal implants and have served to hamper wider acceptance of these IOLs4.

Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Consejo Argentino de Oftalmología

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Men and women that had implantation with Hanita Intensity IOL or Intensity Toric Lenses in the clinic participating in the study. The patients that suffered from cataract and operated with implantation of Hanita Intensity MIOL or Intensity Toric MIOL in the clinic participating in the study.

Description

Inclusion Criteria:

• Patient over the age of 18
• Patient who underwent bilateral implantations with Hanita Lenses Intensity IOL

Exclusion Criteria:

• Patients who don't have any follow up visits after implantation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elder patients diagnosed with cataract; Patients that diagnosed with cataract and had implantation with Hanita Intensity IOL or Intensity Toric Lenses in the clinic participating in the study.	Device: Intra Ocular Lens; Intensity SL Intra Ocular Lens

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.	1-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The second aim of this study is to evaluate the visual phenomena post-operation.	Visual phenomena will be evaluated by asking the patients about halos ang glares	1-3 months

Collaborators and Investigators

• Sponsor: Hanita Lenses

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cataract; Intra Ocular Lens; Hanita Lenses; Intensity SL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: RT-IN1

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