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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06075459
Other study ID # HTF-PM-AR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date September 5, 2023

Study information

Verified date October 2023
Source Hanita Lenses
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Study Design: This study is an ambispective, single arm single center, open label study. Study Objectives: The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. The primary aim of this study is to evaluate the binocular defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation. The second aim of this study is to evaluate the patient satisfaction 12 to 24 months post-operation. Study population: Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation. Enrollment: The study will encompass a total of 60 eligible subjects implanted bilaterally (120 eyes) in total who will complete the protocol follow-up schedule. Duration of Subject participation: Duration of Subject participation is at most one month Completion of active enrolment is anticipated to last approximately 6 months. The primary aim will be finally evaluated when the last study subject has been recruited. Visits & Procedures Patients participating in the trial will attend a total of one visit (1 year follow up visit). Subjects will be selected from the physician's usual subjects' practice. All subjects meeting the inclusion criteria and having signed the Informed Consent Form will be evaluated by the Investigator according to the study protocol. 1 year follow up visit: Pre-operation Visit: performed to check inclusion criteria, and to sign the informed consent.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 5, 2023
Est. primary completion date September 5, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Implanted bilaterally using Hanita Intensity SL IOL - 12 to 24 months post implantation - Signed informed consent Exclusion Criteria: • Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Dr. Nano Eye Clinic 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. 21-24 months post operation
Secondary The second aim of this study is to evaluate the patient satisfaction post-operation. Patient satisfaction will be evaluated by using Quality of Life (VH14) and satisfaction Questionnaire 21-24 months post operation
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