Status:
COMPLETED
Evaluation of Long-term Safety and Performance of PanOptix Intraocular Lens (IOLs)
Lead Sponsor:
Alcon Research
Conditions:
Aphakia
Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof PanOptix Trifocal toric and non-toric IOL models in subjects bilatera...
Detailed Description
Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes repor...
Eligibility Criteria
Inclusion
- Subject or legally authorized representative must be able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
- Subject must have had bilateral implantation of AcrySof PanOptix and/or AcrySof PanOptix Toric IOL models for 3 to 5 years prior to enrollment. A subject may have a Toric lens in one eye and a non-Toric in the fellow eye.
- Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
Exclusion
- Subject currently participating in another investigational drug or device study.
- Subject has had corneal refractive surgery after AcrySof PanOptix or AcrySof PanOptix Toric IOL implantation.
- Subject exposed to a study IOL for a minimum of 3 years prior to Visit 1 that have subsequently undergone an IOL exchange and are no longer implanted with a study IOL at the time of enrollment.
- Subject is pregnant or nursing at the time of enrollment.
Key Trial Info
Start Date :
April 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06166901
Start Date
April 27 2024
End Date
February 5 2025
Last Update
March 12 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitari General de Catalunya
Sabadell, Barcelona, Spain, 8205
2
Oftalvist Jerez - HLA Puerta del Sur
Jerez de la Frontera, Cadiz, Spain, 11408
3
Barraquer Ophthalmology Center
Barcelona, Spain, 08021
4
Institut Catala de la Retina - Sarria
Barcelona, Spain, 8022