Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-07 @ 5:12 PM
Study NCT ID:
NCT06075459
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2023-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
Sponsor:
Hanita Lenses
Organization:
Study Overview
Official Title:
Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Post-op
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.
The study will also evaluate the patient satisfaction of the implanted patients.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: