Status:
COMPLETED
Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
Lead Sponsor:
Hanita Lenses
Conditions:
Cataract
Eligibility:
All Genders
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.
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 pr...
Eligibility Criteria
Inclusion
- Implanted bilaterally using Hanita Intensity SL IOL
- 12 to 24 months post implantation
- Signed informed consent
Exclusion
- • Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06075459
Start Date
March 1 2023
End Date
September 5 2023
Last Update
October 11 2023
Active Locations (1)
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1
Dr. Nano Eye Clinic
Buenos Aires, Argentina, 1655 4 A