Data Collection After Intensity IOL Implantations

NCT06220331 | Completed DMC

• 1 other identifier: RT-IN1
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Intra Ocular Lens; Intensity SL; Hanita Lenses; Cataract

Outcome Measures

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.

  1-3 months

Secondary Outcomes (1)

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

  1-3 months

Study Arms (1)

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

Intra Ocular Lens DEVICE

Intensity SL Intra Ocular Lens

Elder patients diagnosed with cataract

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

Consejo Argentino de Oftalmología

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: July 13, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)