Clinical trial NCT06166901: Evaluation of Long-term Safety and Performance of PanOptix Intraocular Lens (IOLs)
Official title: Evaluation of Long-term Safety and Performance of AcrySof PanOptix Trifocal & PanOptix Toric Trifocal Intraocular Lens (IOLs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Astigmatism
Presbyopia
Keywords: Cataract surgery
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-12-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.

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 reported prior to enrollment. Prospective data will be collected at Visit 1, which will occur Year 3-5 postoperative.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
timeFrame: Visit 1 (Year 3-5 postoperative)
measure: Number of Adverse Events (AEs)
timeFrame: Preoperative to Visit 1 (Year 3-5 postoperative)
measure: Number of Device Deficiencies
timeFrame: Preoperative to Visit 1 (Year 3-5 postoperative)
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitari General de Catalunya
state: Barcelona
city: Jerez De La Frontera
country: Spain
facility: Oftalvist Jerez - HLA Puerta del Sur
state: Cadiz
city: Barcelona
country: Spain
facility: Barraquer Ophthalmology Center
city: Barcelona
country: Spain
facility: Institut Catala de la Retina - Sarria
city: Cordoba
country: Spain
facility: Hospital Arruzafa
city: Madrid
country: Spain
facility: Miranza IOA
city: Madrid
country: Spain
facility: Clinicas Novovision - Clinica Madrid
Study officials:
affiliation: Alcon Research
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: