Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)

Alcon Research211 enrolled

Overview

The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term safety and performance of the AcrySof IQ PanOptix IOL toric and non-toric models in subjects bilaterally implanted with these IOLs for 3 to 5 years. This study will be conducted in Spain.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

211

Conditions

Aphakia Astigmatism Presbyopia

Interventions

AcrySof IQ PanOptix IOL ToricDEVICE

Trifocal toric IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia who desire near, intermediate and distance vision with increased spectacle independence.

AcrySof IQ PanOptix IOL Non-ToricDEVICE

Trifocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism with and without presbyopia who desire near, intermediate and distance vision with increased spectacle independence.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Hospital Universitari General de Catalunya

Sabadell, Barcelona, Spain

Oftalvist Jerez - HLA Puerta del Sur

Jerez de la Frontera, Cadiz, Spain

Barraquer Ophthalmology Center

Barcelona, Spain

Institut Catala de la Retina - Sarria

Barcelona, Spain

Outcomes

Primary Outcomes

Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)

BCDVA was assessed for both eyes together at a distance of 4 meters using letter charts and recorded in logarithm of the minimum angle of resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL were categorized as toric as specified in the statistical analysis plan. No hypothesis testing was pre-specified for this endpoint.

Time frame: Year 3-5 postoperative (Visit 1, Day 1)

Number of Eyes Experiencing an Ocular Adverse Event by Toricity

Ocular adverse events were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of ocular adverse events include the following: * Cystoid Macular Edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary block * Retinal detachment * Secondary Surgical Interventions (explantation/exchange/repositioning) This outcome measure was pre-specified for eye-based reporting.

Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Number of Subjects Experiencing a Non-Ocular Adverse Event

AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative).

Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)

Number of Device Deficiencies by Toricity

Device deficiencies were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of device deficiencies include the following: * Failure to meet product specifications (e.g., incorrect IOL power) * IOL defect * Broken IOL optic * Broken IOL haptic * Scratched IOL optic * Unsealed device packaging * Suspected product contamination * Lack of performance This outcome measure was pre-specified for eye-based reporting.

Data from ClinicalTrials.gov

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