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The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.
Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye.
Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.
This study will be conducted in Australia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanOptix Toric Trifocal IOL | Experimental | PanOptix Toric Trifocal IOL implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACRYSOF® IQ PanOptix® Toric Trifocal IOL | Device | Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined | Manifest cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Residual manifest cylinder was measured in diopters and reported in plus cylinder form, with a smaller number indicating a lesser amount of added correction. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure. | Month 3 postoperative, Month 6 postoperative |
| Percentage of Eyes With IOL Rotation Less Than 10 Degrees | IOL rotation was defined as the difference in IOL axis of orientation from Day 1 postoperative. IOL rotation was assessed by the investigator using a slit lamp and was recorded in degrees, with a smaller number indicating less rotation. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure. | Month 3 postoperative, Month 6 postoperative |
| Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) | Visual acuity (VA) was assessed at a distance of 4 meters with refractive correction in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure. | Month 3 postoperative, Month 6 postoperative |
| Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | Visual acuity (VA) was assessed at a distance of 60 meters with distance correction (plus or minus power) in place. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 8117 | Campsie | New South Wales | 2194 | Australia | ||
| Alcon Investigator 7678 |
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A total of 58 subjects were enrolled in the study (i.e., signed informed consent), of whom 4 were screen failures. This reporting group includes all subjects (54) implanted with the IOL in one or both eyes.
Subjects were recruited from 4 investigative sites located in Australia.
| ID | Title | Description |
|---|---|---|
| FG000 | PanOptix Toric Trifocal IOL | PanOptix Toric Trifocal intraocular lens (IOL) implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes were implanted (bilateral implantation). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Implanted Analysis Set: All eyes with successful IOL implantation with at least one post-operative visit
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| ID | Title | Description |
|---|---|---|
| BG000 | PanOptix Toric Trifocal IOL | PanOptix Toric Trifocal intraocular lens (IOL) implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes were implanted (bilateral implantation). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined | Manifest cylinder is the amount of added correction needed to compensate for any astigmatism that may be present. A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. Residual manifest cylinder was measured in diopters and reported in plus cylinder form, with a smaller number indicating a lesser amount of added correction. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure. | All-Implanted Analysis Set (AAS): All eyes with successful IOL implantation with at least one post-operative visit and data at study visit | Posted | Mean | Standard Deviation | diopter | Month 3 postoperative, Month 6 postoperative | eyes | eyes |
|
Adverse events (AEs) were collected from time of consent to Day 180-210 post-treatment/study exit, up to 8 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
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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 | Pretreatment | Events reported in this group occurred prior to attempted implantation with the test article |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal erosion | Eye disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Projects, 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 | Jul 30, 2020 | Dec 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2021 | Dec 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D001251 | Astigmatism |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
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| Cataract surgery | Procedure | Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use |
|
| Month 3 postoperative, Month 6 postoperative |
| Mean Binocular Distance Corrected Near Visual Acuity (DCNVA) | Visual acuity (VA) was assessed at a distance of 40 centimeters with distance correction (plus or minus power) in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure. | Month 3 postoperative, Month 6 postoperative |
| Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category | A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. SSIs are reported categorically as SSIs related to the IOL and due to optical properties, SSIs related to the IOL and not due to optical properties, and SSIs unrelated to the IOL. | Up to Month 6 postoperative |
| Percentage of Subjects With a Severe Visual Disturbance | The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding "Yes" were then asked to rate how severe their worst experience was during the past 7 days. Subjects responded on a 5-point scale: 0=None; 1=A little; 2=Mild; 3=Moderate; 4=Severe. Subjects responding "No" were automatically imputed as reporting, "0=None." Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure. | Preoperative, Month 3 postoperative, Month 6 postoperative |
| Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID) | QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding "Yes" were then asked to rate how severe their worst experience was with the vision-related experience in the past 7 days. Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all. Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure. | Preoperative, Month 3 postoperative, Month 6 postoperative |
| Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects | An adverse event (AE) was defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure. | Up to Month 6 postoperative |
| Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects | An adverse event (AE) was defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure. | Up to Month 6 postoperative |
| Sydney |
| New South Wales |
| 2150 |
| Australia |
| Alcon Investigator 7813 | Footscray | Victoria | 3011 | Australia |
| Alcon Investigator 8122 | Saint Albans | Victoria | 3021 | Australia |
| Patient Unable to Attend |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Specific Asian Nationality | Count of Participants | Participants | No |
|
|
|
| Primary | Percentage of Eyes With IOL Rotation Less Than 10 Degrees | IOL rotation was defined as the difference in IOL axis of orientation from Day 1 postoperative. IOL rotation was assessed by the investigator using a slit lamp and was recorded in degrees, with a smaller number indicating less rotation. Eyes were assessed individually and combined for the analysis. No formal statistical hypothesis testing was prespecified for this outcome measure. | AAS | Posted | Number | percentage of eyes | Month 3 postoperative, Month 6 postoperative | eyes | eyes |
|
|
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| Primary | Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) | Visual acuity (VA) was assessed at a distance of 4 meters with refractive correction in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure. | AAS | Posted | Mean | Standard Deviation | logMAR | Month 3 postoperative, Month 6 postoperative |
|
|
|
| Primary | Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | Visual acuity (VA) was assessed at a distance of 60 meters with distance correction (plus or minus power) in place. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure. | AAS | Posted | Mean | Standard Deviation | logMAR | Month 3 postoperative, Month 6 postoperative |
|
|
|
| Primary | Mean Binocular Distance Corrected Near Visual Acuity (DCNVA) | Visual acuity (VA) was assessed at a distance of 40 centimeters with distance correction (plus or minus power) in place using a visual acuity chart. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.0 logMAR corresponding to 20/20 Snellen visual acuity, or normal distance eyesight. Eyes were assessed binocularly (eyes together). A lower value denotes better visual acuity. No formal statistical hypothesis testing was prespecified for this outcome measure. | AAS | Posted | Mean | Standard Deviation | logMAR | Month 3 postoperative, Month 6 postoperative |
|
|
|
| Primary | Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category | A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. SSIs are reported categorically as SSIs related to the IOL and due to optical properties, SSIs related to the IOL and not due to optical properties, and SSIs unrelated to the IOL. | Safety Analysis Set (SAS): All eyes with attempted IOL implantation, successful or aborted after contact with the eye, and data at study visit | Posted | Number | percentage of eyes | Up to Month 6 postoperative | eyes | eyes |
|
|
|
| Primary | Percentage of Subjects With a Severe Visual Disturbance | The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding "Yes" were then asked to rate how severe their worst experience was during the past 7 days. Subjects responded on a 5-point scale: 0=None; 1=A little; 2=Mild; 3=Moderate; 4=Severe. Subjects responding "No" were automatically imputed as reporting, "0=None." Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure. | SAS | Posted | Number | 95% Confidence Interval | percentage of participants | Preoperative, Month 3 postoperative, Month 6 postoperative |
|
|
|
| Primary | Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID) | QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about 7 vision-related experiences. For each experience, the subject was asked if he/she had experienced it during the past 7 days. Subjects responding "Yes" were then asked to rate how severe their worst experience was with the vision-related experience in the past 7 days. Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all. Percentage was calculated as number of subjects with response in specified category divided by number of subjects with data regardless of response, times 100. No formal statistical hypothesis testing was prespecified for this outcome measure. | SAS | Posted | Number | 95% Confidence Interval | percentage of participants | Preoperative, Month 3 postoperative, Month 6 postoperative |
|
|
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| Primary | Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects | An adverse event (AE) was defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure. | SAS | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 6 postoperative |
|
|
|
| Primary | Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects | An adverse event (AE) was defined as untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No formal statistical hypothesis testing was prespecified for this outcome measure. | SAS | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 6 postoperative |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | PanOptix Toric First Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye | 0 | 54 | 1 | 54 | 5 | 54 |
| EG002 | PanOptix Toric Second Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye | 0 | 51 | 1 | 51 | 4 | 51 |
| EG003 | PanOptix Toric Systemic | Events reported in this group occurred after attempted implantation with the test article | 0 | 54 | 1 | 54 | 0 | 54 |
| Diabetic retinal oedema | Eye disorders | MedDRA (23.1) | Systematic Assessment |
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| Iris adhesions | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (23.1) | Systematic Assessment |
|
| Intra-ocular injection | Surgical and medical procedures | MedDRA (23.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Month 6 postoperative |
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| SSIs Unrelated to the IOL |
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| Halos - Severe |
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| Glare - Severe |
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| Hazy Vision - Severe |
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| Blurred Vision - Severe |
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| Double Vision - Severe |
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| Dark Area - Severe |
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| Halos - Bothered very much |
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| Glare - Bothered very much |
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| Hazy Vision - Bothered very much |
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| Blurred Vision - Bothered very much |
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| Double Vision - Bothered very much |
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| Dark Area - Bothered very much |
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| Iris adhesions |
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