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OpenTrials
Completed

NCT Number: NCT06220331

Data Collection After Intensity IOL Implantations

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Consejo Argentino de Oftalmología

Buenos Aires, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra Ocular Lens

Device

Intensity SL Intra Ocular Lens

Primary outcomes

  1. The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.

    Time frame: 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 outcomes

  1. The second aim of this study is to evaluate the visual phenomena post-operation.

    Time frame: 1-3 months

    Visual phenomena will be evaluated by asking the patients about halos ang glares

Sponsors and collaborators

Lead sponsor

Hanita Lenses

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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