Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
NCT ID: NCT06075459
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2023-03-01
2023-09-05
Brief Summary
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The study will also evaluate the patient satisfaction of the implanted patients.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 12 to 24 months post implantation
* Signed informed consent
Exclusion Criteria
ALL
No
Sponsors
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Hanita Lenses
INDUSTRY
Responsible Party
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Principal Investigators
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German Bianchi, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. Nano Eye Clinic
Locations
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Dr. Nano Eye Clinic
Buenos Aires, , Argentina
Countries
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Other Identifiers
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HTF-PM-AR
Identifier Type: -
Identifier Source: org_study_id
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