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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof IQ PanOptix IOL Toric | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| 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). | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari General de Catalunya | Sabadell | Barcelona | 8205 | Spain | ||
| Oftalvist Jerez - HLA Puerta del Sur |
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Of the 211 enrolled, 3 subjects were exited as screen failures. This reporting group includes all enrolled subjects who passed screening (Full Analysis Set). Note: 34 subjects were implanted with toric in one eye and non-toric in the other eye.
Subjects were recruited from 7 investigative sites located in Spain.
| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof IQ PanOptix Toric | AcrySof IQ PanOptix IOL Toric in both eyes |
| FG001 | AcrySof IQ PanOptix Non-Toric | AcrySof IQ PanOptix IOL Non-Toric in both eyes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof IQ PanOptix IOL Toric | Subjects that 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 |
| BG001 | AcrySof IQ PanOptix IOL Non Toric |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | LogMAR | Year 3-5 postoperative (Visit 1, Day 1) |
|
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.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AcrySof IQ PanOptix IOL Toric First Implanted Eye | Eye implanted with AcrySof IQ PanOptix IOL Toric |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Lead, CRD Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2025 | Jan 30, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2025 | Jan 30, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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|
|
| AcrySof IQ PanOptix IOL Non-Toric | Device | 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. |
|
|
| Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1) |
| Jerez de la Frontera |
| Cadiz |
| 11408 |
| Spain |
| Barraquer Ophthalmology Center | Barcelona | 08021 | Spain |
| Institut Catala de la Retina - Sarria | Barcelona | 8022 | Spain |
| Hospital Arruzafa | Córdoba | 14012 | Spain |
| Miranza IOA | Madrid | 28033 | Spain |
| Clinicas Novovision - Clinica Madrid | Madrid | 28046 | Spain |
Subjects that were implanted with AcrySof IQ PanOptix IOL Non Toric in both eyes 3-5 years prior to enrollment |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 | AcrySof IQ PanOptix IOL Non-Toric | Subjects that were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment |
|
|
| Primary | 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:
| All enrolled eyes that passed screening. | Posted | Number | eye | Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1) | eyes | eyes |
|
|
|
| Primary | 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). | All enrolled subjects that passed screening. Subjects with at least one implanted eye with a toric IOL were categorized as toric as specified in the statistical analysis plan. | Posted | Number | subject | Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1) |
|
|
|
| Primary | 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:
| All enrolled eyes that passed screening. | Posted | Number | device deficiencies | Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1) | eyes | eyes |
|
|
|
| 0 |
| 0 |
| 0 |
| 90 |
| 42 |
| 90 |
| EG001 | AcrySof IQ PanOptix IOL Toric Second Implanted Eye | Eye implanted with AcrySof IQ PanOptix IOL Toric | 0 | 0 | 2 | 82 | 49 | 82 |
| EG002 | AcrySof IQ PanOptix IOL Toric Systemic | Subject implanted with AcrySof IQ PanOptix IOL (Toric or Non Toric) with at least one of the eyes implanted with AcrySof IQ PanOptix Toric IOL | 0 | 103 | 1 | 103 | 0 | 103 |
| EG003 | AcrySof IQ PanOptix IOL Non-Toric First Implanted Eye | Eye implanted with AcrySof IQ PanOptix IOL Non Toric | 0 | 0 | 1 | 118 | 55 | 118 |
| EG004 | AcrySof IQ PanOptix IOL Non-Toric Second Implanted Eye | Eye implanted with AcrySof IQ PanOptix IOL Non Toric | 0 | 0 | 2 | 126 | 52 | 126 |
| EG005 | AcrySof IQ PanOptix IOL Non-Toric Systemic | Subject implanted with AcrySof IQ PanOptix IOL Non Toric in both eyes | 0 | 105 | 2 | 105 | 0 | 105 |
| Retinal oedema | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
| Cystoid macular oedema | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Device material issue | Product Issues | MedDRA 26.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 26.1 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.