AphakiaNCT06166901
Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)
A study testing AcrySof IQ PanOptix IOL Toric and AcrySof IQ PanOptix IOL Non-Toric in people with Aphakia and Astigmatism, run by Alcon Research at 7 sites in Spain.
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 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphakia, Astigmatism, Presbyopia
- What is being tested?
- AcrySof IQ PanOptix IOL Toric and AcrySof IQ PanOptix IOL Non-Toric
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 7 sitesSpain
- Study dates
- 27 Apr 2024to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Barraquer Ophthalmology Center
Barcelona, 08021
Institut Catala de la Retina - Sarria
Barcelona, 8022
Hospital Arruzafa
Córdoba, 14012
Oftalvist Jerez - HLA Puerta del Sur
Jerez de la Frontera, Cadiz, 11408
Miranza IOA
Madrid, 28033
Clinicas Novovision - Clinica Madrid
Madrid, 28046
Hospital Universitari General de Catalunya
Sabadell, Barcelona, 8205
About this study
Official title: Evaluation of Long-term Safety and Performance of AcrySof PanOptix Trifocal & PanOptix Trifocal Toric Intraocular Lens (IOL)
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.
Read the 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
- Being tested
- AcrySof IQ PanOptix IOL Toric, AcrySof IQ PanOptix IOL Non-Toric
- Keywords
- Cataract surgery
- Medical subject headings
- Aphakia, Astigmatism, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof IQ PanOptix IOL ToricDevice
Also called Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60
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
Also called Model TFNT00
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.
| Study group | Role | What they receive |
|---|---|---|
| AcrySof IQ PanOptix IOL Toric | Experimental | 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 Receives: Device: AcrySof IQ PanOptix IOL Toric; Device: AcrySof IQ PanOptix IOL Non-Toric |
| AcrySof IQ PanOptix IOL Non-Toric | Experimental | Subjects categorized to this group were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment Receives: Device: AcrySof IQ PanOptix IOL Non-Toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start27 Apr 2024
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphakiaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166901
- Sponsor's protocol ID
- ILH297-I001
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2023
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Safety and Performance of AcrySof PanOptix Trifocal & PanOptix Trifocal Toric Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT06166901
- Acronym / sponsor ID
- ILH297-I001
- Conditions
- Aphakia, Astigmatism, Presbyopia
- Keywords
- Cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AcrySof IQ PanOptix IOL Toric | Experimental | Device: AcrySof IQ PanOptix IOL Toric, Device: AcrySof IQ PanOptix IOL Non-ToricSubjects 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 |
| AcrySof IQ PanOptix IOL Non-Toric | Experimental | Device: AcrySof IQ PanOptix IOL Non-ToricSubjects categorized to this group were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcrySof IQ PanOptix IOL ToricAlso: Models TFNT20, TFNT30, TFNT40, TFNT50, TFNT60Trifocal 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 Toric |
| AcrySof IQ PanOptix IOL Non-ToricAlso: Model TFNT00Trifocal 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. | Device | AcrySof IQ PanOptix IOL Non-Toric, AcrySof IQ PanOptix IOL Toric |
Primary outcome
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
Time frame: Year 3-5 postoperative (Visit 1, Day 1)
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.
Number of Eyes Experiencing an Ocular Adverse Event by Toricity
Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
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.
Number of Subjects Experiencing a Non-Ocular Adverse Event
Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative).
Number of Device Deficiencies by Toricity
Time frame: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Vision Care study director
Alcon Research
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof IQ PanOptix IOL Toric and AcrySof IQ PanOptix IOL Non-Toric in people with Aphakia and Astigmatism, run by Alcon Research at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) (time frame: Year 3-5 postoperative (Visit 1, Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.