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CompletedNCT06220331Updated Jan 23, 2024

Data Collection After Intensity IOL Implantations

An observational study in Cataract, sponsored by Hanita Lenses. Completed at 1 site in Argentina. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Hanita Lenses · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
31
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract

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Keywords

  • Intra Ocular Lens
  • Intensity SL
  • Hanita Lenses
  • Cataract
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 31 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Hanita Lenses is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who don't have any follow up visits after implantation
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceIntra Ocular Lens

    Intensity SL Intra Ocular Lens

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-3 months

Secondary outcomes

  1. 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

    Time frame: 1-3 months

07

Study locations

1 site
  • Consejo Argentino de Oftalmología
    Buenos Aires, Argentina
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06220331
Lead sponsor
Hanita Lenses
Responsible party
Sponsor
First posted
Jan 23, 2024
Start date
Jul 13, 2023
Primary completion
Sep 1, 2023
Completion
Sep 30, 2023
Last update
Jan 23, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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