Data Collection After Intensity IOL Implantations

Completed

• Conditions: Cataract
• Interventions: Device: Intra Ocular Lens

• Registration Number: NCT06220331
• Lead Sponsor: Hanita Lenses

Brief Summary

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.

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 Timeline

• Study Start: 2023-07-13
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elder patients diagnosed with cataract	Intra Ocular Lens	Patients that diagnosed with cataract and had implantation with Hanita Intensity IOL or Intensity Toric Lenses in the clinic participating in the study.

Primary Outcome Measures

Name	Time	Method
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.	1-3 months	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 visual phenomena post-operation.	1-3 months	Visual phenomena will be evaluated by asking the patients about halos ang glares

Trial Locations

Locations (1)

Consejo Argentino de Oftalmología; 🇦🇷 Buenos Aires, Argentina