An interventional study of AcrySof IQ PanOptix IOL Toric and AcrySof IQ PanOptix IOL Non-Toric in Aphakia, Astigmatism and Presbyopia, sponsored by Alcon Research. Completed at 7 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Basic science
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 211 is above the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects categorized to this group were implanted with AcrySof IQ PanOptix IOL (Toric or Non-Toric) in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with AcrySof IQ PanOptix IOL Toric
Device: AcrySof IQ PanOptix IOL Toric · Device: AcrySof IQ PanOptix IOL Non-Toric
Subjects categorized to this group were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment
Device: AcrySof IQ PanOptix IOL Non-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.
Also known as: Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60
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.
Also known as: Model TFNT00
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.
Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
Subjects were recruited from 7 investigative sites located in Spain.
| Milestone | AcrySof IQ PanOptix Toric | AcrySof IQ PanOptix Non-Toric |
|---|---|---|
| Started | 103 | 139 |
| Both eyes implanted | 69 | 105 |
| One eye implanted | 34 | 34 |
| Completed | 103 | 139 |
| Not completed | 0 | 0 |
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.
| LogMAR | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non-Toric |
|---|---|---|
| Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) | -0.019 ± 0.0815 | -0.012 ± 0.0660 |
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.
| eye | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non-Toric |
|---|---|---|
| Number of Eyes Experiencing an Ocular Adverse Event by Toricity | 108 | 120 |
AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative).
| subject | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non-Toric |
|---|---|---|
| Number of Subjects Experiencing a Non-Ocular Adverse Event | 14 | 6 |
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.
| device deficiencies | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non-Toric |
|---|---|---|
| Number of Device Deficiencies by Toricity | 2 | 8 |
Collected over AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AcrySof IQ PanOptix IOL Toric First Implanted Eye | — | 0/90 (0%) | 42/90 (46.7%) |
| AcrySof IQ PanOptix IOL Toric Second Implanted Eye | — | 2/82 (2.4%) | 49/82 (59.8%) |
| AcrySof IQ PanOptix IOL Toric Systemic | 0/103 (0%) | 1/103 (1%) | 0/103 (0%) |
| AcrySof IQ PanOptix IOL Non-Toric First Implanted Eye | — | 1/118 (0.8%) | 55/118 (46.6%) |
| AcrySof IQ PanOptix IOL Non-Toric Second Implanted Eye | — | 2/126 (1.6%) | 52/126 (41.3%) |
| AcrySof IQ PanOptix IOL Non-Toric Systemic | 0/105 (0%) | 2/105 (1.9%) | 0/105 (0%) |
| Event | AcrySof IQ PanOptix IOL Toric First Implanted Eye | AcrySof IQ PanOptix IOL Toric Second Implanted Eye | AcrySof IQ PanOptix IOL Toric Systemic | AcrySof IQ PanOptix IOL Non-Toric First Implanted Eye | AcrySof IQ PanOptix IOL Non-Toric Second Implanted Eye | AcrySof IQ PanOptix IOL Non-Toric Systemic |
|---|---|---|---|---|---|---|
| Cystoid macular oedemaEye disorders | 0/90 | 0/82 | — | 0/118 | 2/126 | — |
| Retinal detachmentEye disorders | 0/90 | 1/82 | — | 0/118 | 0/126 | — |
| Retinal oedemaEye disorders | 0/90 | 1/82 | — | 1/118 | 0/126 | — |
| Breast neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | 1/103 | — | — | 1/105 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | 0/103 | — | — | 1/105 |
| Event | AcrySof IQ PanOptix IOL Toric First Implanted Eye | AcrySof IQ PanOptix IOL Toric Second Implanted Eye | AcrySof IQ PanOptix IOL Toric Systemic | AcrySof IQ PanOptix IOL Non-Toric First Implanted Eye | AcrySof IQ PanOptix IOL Non-Toric Second Implanted Eye | AcrySof IQ PanOptix IOL Non-Toric Systemic |
|---|---|---|---|---|---|---|
| Posterior capsule opacificationEye disorders | 25/90 | 33/82 | — | 31/118 | 31/126 | — |
| Dry eyeEye disorders | 10/90 | 14/82 | — | 15/118 | 12/126 | — |
| Vitreous detachmentEye disorders | 14/90 | 13/82 | — | 11/118 | 9/126 | — |
| BlepharitisEye disorders | 9/90 | 11/82 | — | 13/118 | 13/126 | — |
| Device material issueProduct Issues | 3/90 | 2/82 | — | 11/118 | 10/126 | — |
Full Analysis Set
| Age, Customized(Participants) | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non Toric | Total |
|---|---|---|---|
| Less than 65 years | 35 | 38 | 73 |
| Equal to or greater than 65 years | 68 | 67 | 135 |
| Sex: Female, Male(Participants) | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non Toric | Total |
|---|---|---|---|
| Female | 64 | 68 | 132 |
| Male | 39 | 37 | 76 |
| Ethnicity (NIH/OMB)(Participants) | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non Toric | Total |
|---|---|---|---|
| Hispanic or Latino | 58 | 67 | 125 |
| Not Hispanic or Latino | 45 | 38 | 83 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non Toric | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Black or African American | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| White | 103 | 104 | 207 |
| Other | 0 | 0 | 0 |
| Region of Enrollment(participants) | AcrySof IQ PanOptix IOL Toric | AcrySof IQ PanOptix IOL Non Toric | Total |
|---|---|---|---|
| Spain | 103 | 105 | 208 |
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