NCT06166901

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Aphakia
• Astigmatism
• Presbyopia

Interventions

Type	Name	Description
DEVICE	AcrySof IQ PanOptix IOL Toric	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.
DEVICE	AcrySof IQ PanOptix IOL Non-Toric	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.

Timeline

• Start date: 2024-04-27
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2023-12-12
• Last updated: 2026-03-23
• Results posted: 2026-03-23

Locations

7 sites across 1 country: Spain

Regulatory

• FDA-regulated device study