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

Presbyopia Clinical Trial

Official title:

Evaluation of Long-term Safety and Performance of AcrySof PanOptix Trifocal & PanOptix Toric Trifocal Intraocular Lens (IOLs)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166901
• Other study ID #: ILH297-I001
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Astigmatism
• Presbyopia

Intervention

Device:
• AcrySof IQ PanOptix IOL
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.
• AcrySof IQ PanOptix Toric IOL
Toric trifocal 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.

Locations

Country	Name	City	State
Spain	Barraquer Ophthalmology Center	Barcelona
Spain	Institut Catala de la Retina - Sarria	Barcelona
Spain	Hospital Arruzafa	Cordoba
Spain	Oftalvist Jerez - HLA Puerta del Sur	Jerez De La Frontera	Cadiz
Spain	Clinicas Novovision - Clinica Madrid	Madrid
Spain	Miranza IOA	Madrid
Spain	Hospital Universitari General de Catalunya	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)	BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).	Visit 1 (Year 3-5 postoperative)
Primary	Number of Adverse Events (AEs)	Ocular adverse events will be identified from chart review and prospectively at Visit 1. 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)	Preoperative to Visit 1 (Year 3-5 postoperative)
Primary	Number of Device Deficiencies	Device deficiencies will be identified from chart review and prospectively at Visit 1. 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	Preoperative to Visit 1 (Year 3-5 postoperative)