Data Collection After Intensity IOL Implantations

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06220331
• Other study ID #: RT-IN1
• Status: Completed
• Start date: July 13, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Hanita Lenses
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Intra Ocular Lens
Intensity SL Intra Ocular Lens

Locations

Country	Name	City	State
Argentina	Consejo Argentino de Oftalmología	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.	1-3 months
Secondary	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