NCT06075459

Brief Summary

This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation. The study will also evaluate the patient satisfaction of the implanted patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 4, 2023

Last Update Submit

October 10, 2023

Conditions

Cataract

Keywords

CataractIOLHanita Lenses

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.

    21-24 months post operation

Secondary Outcomes (1)

  • The second aim of this study is to evaluate the patient satisfaction post-operation.

    21-24 months post operation

Study Arms (1)

Implanted patients with Intensity IOLs, 12-24 months previously

Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.

You may qualify if:

  • Implanted bilaterally using Hanita Intensity SL IOL
  • to 24 months post implantation
  • Signed informed consent

You may not qualify if:

  • Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Nano Eye Clinic

Buenos Aires, 1655 4 A, Argentina

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • German Bianchi, MD

    Dr. Nano Eye Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

March 1, 2023

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)