N/A
N=242
Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)
Aphakia · Astigmatism · Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT06166901 ↗Enrolled (actual)
242
Serious AEs
1.3%
Results posted
Mar 2026
Primary outcome: Primary: Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) — -0.019; -0.012 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcrySof IQ PanOptix IOL Toric (Device); AcrySof IQ PanOptix IOL Non-Toric (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) |
-0.019; -0.012 | — |
| PRIMARY Number of Eyes Experiencing an Ocular Adverse Event by Toricity |
108; 120 | — |
| PRIMARY Number of Subjects Experiencing a Non-Ocular Adverse Event |
14; 6 | — |
| PRIMARY Number of Device Deficiencies by Toricity |
2; 8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06166901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.