An interventional study of ACRYSOF® IQ PanOptix® Toric Trifocal IOL and Cataract surgery in Aphakia and Corneal Astigmatism, sponsored by Alcon Research. Completed at 4 sites in Australia. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-12-30.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 58 is below 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.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: ACRYSOF® IQ PanOptix® Toric Trifocal IOL · Procedure: Cataract surgery
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.
Also known as: PanOptix Toric Trifocal IOL, Models TFNT30, TFNT40, TFNT50, TFNT60
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Month 6 postoperative
Subjects were recruited from 4 investigative sites located in Australia.
| Milestone | PanOptix Toric Trifocal IOL |
|---|---|
| Started | 54 |
| First eye implanted | 54 |
| Second eye implanted | 51 |
| Completed | 50 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Patient unable to come | 1 |
| Withdrew: Patient unable to attend | 1 |
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.
| diopter | All Eyes |
|---|---|
| Month 3 postoperative | 0.219 ± 0.2388 |
| Month 6 postoperative | 0.198 ± 0.2392 |
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.
| percentage of eyes | All Eyes |
|---|---|
| Month 3 postoperative | 100 |
| Month 6 postoperative | 100 |
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.
| logMAR | PanOptix Toric Trifocal IOL |
|---|---|
| Month 3 postoperative | 0.043 ± 0.0881 |
| Month 6 postoperative | 0.022 ± 0.0810 |
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.
| logMAR | PanOptix Toric Trifocal IOL |
|---|---|
| Month 3 postoperative | 0.075 ± 0.1068 |
| Month 6 postoperative | 0.089 ± 0.1074 |
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.
| logMAR | PanOptix Toric Trifocal IOL |
|---|---|
| Month 3 postoperative | 0.161 ± 0.0924 |
| Month 6 postoperative | 0.139 ± 0.0886 |
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.
| percentage of eyes | PanOptix Toric Trifocal IOL - First Eye | PanOptix Toric Trifocal IOL - Second Eye | PanOptix Toric Trifocal IOL - All Eyes |
|---|---|---|---|
| SSIs Related to IOL - Due to Optical Properties | 0.0 | 0.0 | 0.0 |
| SSIs Related to the IOL - Not Due to Optical Properties | 0.0 | 0.0 | 0.0 |
| SSIs Unrelated to the IOL | 1.9 | 2.0 | 1.9 |
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.
| percentage of participants | PanOptix Toric Trifocal IOL - Preoperative | PanOptix Toric Trifocal IOL - Month 3 | PanOptix Toric Trifocal IOL - Month 6 |
|---|---|---|---|
| Starbursts - Severe | 11.8 (4.4 to 23.9) | 17.0 (7.6 to 30.8) | 14.9 (6.2 to 28.3) |
| Halos - Severe | 9.8 (3.3 to 21.4) | 6.3 (1.3 to 17.2) | 0.0 (0.0 to 7.5) |
| Glare - Severe | 19.6 (9.8 to 33.1) | 8.3 (2.3 to 20.0) | 6.5 (1.4 to 17.9) |
| Hazy Vision - Severe | 9.8 (3.3 to 21.4) | 0.0 (0.0 to 7.4) | 0.0 (0.0 to 7.5) |
| Blurred Vision - Severe | 18.0 (8.6 to 31.2) | 0.0 (0.0 to 7.4) | 0.0 (0.0 to 7.5) |
| Double Vision - Severe | 2.0 (0.0 to 10.4) | 0.0 (0.0 to 7.4) | 0.0 (0.0 to 7.5) |
| Dark Area - Severe | 2.0 (0.0 to 10.4) | 0.0 (0.0 to 7.4) | 0.0 (0.0 to 7.5) |
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.
| percentage of participants | PanOptix Toric Trifocal IOL - Preoperative | PanOptix Toric Trifocal IOL - Month 3 | PanOptix Toric Trifocal IOL - Month 6 |
|---|---|---|---|
| Starbursts - Bothered very much | 9.8 (3.3 to 21.4) | 4.2 (0.5 to 14.3) | 2.1 (0.1 to 11.3) |
| Halos - Bothered very much | 7.8 (2.2 to 18.9) | 0.0 (0.0 to 7.4) | 2.1 (0.1 to 11.3) |
| Glare - Bothered very much | 21.6 (11.3 to 35.3) | 6.3 (1.3 to 17.2) | 0.0 (0.0 to 7.5) |
| Hazy Vision - Bothered very much | 13.7 (5.7 to 26.3) | 0.0 (0.0 to 7.4) | 0.0 (0.0 to 7.5) |
| Blurred Vision - Bothered very much | 20.0 (10.0 to 33.7) | 2.1 (0.1 to 11.1) | 2.1 (0.1 to 11.3) |
| Double Vision - Bothered very much | 5.9 (1.2 to 16.2) | 0.0 (0.0 to 7.4) | 0.0 (0.0 to 7.5) |
| Dark Area - Bothered very much | 3.9 (0.5 to 13.5) | 0.0 (0.0 to 7.4) | 0.0 (0.0 to 7.5) |
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.
| percentage of participants | PanOptix Toric Trifocal IOL - First Eye | PanOptix Toric Trifocal IOL - Second Eye |
|---|---|---|
| Diabetic retinal oedema | 1.9 (0.5 to 9.89) | 0.0 (0.0 to 6.98) |
| Intra-ocular injection | 1.9 (0.5 to 9.89) | 0.0 (0.0 to 6.98) |
| Iris adhesions | 0.0 (0.0 to 6.60) | 2.0 (0.05 to 10.45) |
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.
| percentage of participants | PanOptix Toric Trifocal IOL |
|---|---|
| Coronary arterial stent insertion | 1.9 (0.05 to 9.89) |
| Coronary artery disease | 1.9 (0.05 to 9.89) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| PanOptix Toric First Eye | 0/54 (0%) | 1/54 (1.9%) | 5/54 (9.3%) |
| PanOptix Toric Second Eye | 0/51 (0%) | 1/51 (2%) | 4/51 (7.8%) |
| PanOptix Toric Systemic | 0/54 (0%) | 1/54 (1.9%) | 0/54 (0%) |
| Event | Pretreatment | PanOptix Toric First Eye | PanOptix Toric Second Eye | PanOptix Toric Systemic |
|---|---|---|---|---|
| Iris adhesionsEye disorders | 0/54 | 0/54 | 1/51 | 0/54 |
| Coronary artery diseaseCardiac disorders | 0/54 | 0/54 | 0/51 | 1/54 |
| Diabetic retinal oedemaEye disorders | 0/54 | 1/54 | 0/51 | 0/54 |
| Coronary arterial stent insertionSurgical and medical procedures | 0/54 | 0/54 | 0/51 | 1/54 |
| Intra-ocular injectionSurgical and medical procedures | 0/54 | 1/54 | 0/51 | 0/54 |
| Event | Pretreatment | PanOptix Toric First Eye | PanOptix Toric Second Eye | PanOptix Toric Systemic |
|---|---|---|---|---|
| Corneal erosionEye disorders | 0/54 | 3/54 | 2/51 | 0/54 |
| Dry eyeEye disorders | 0/54 | 3/54 | 2/51 | 0/54 |
All Implanted Analysis Set: All eyes with successful IOL implantation with at least one post-operative visit
| Age, Continuous(years) | PanOptix Toric Trifocal IOL |
|---|---|
| Mean | 66.8 ± 9.99 |
| Sex: Female, Male(Participants) | PanOptix Toric Trifocal IOL |
|---|---|
| Female | 36 |
| Male | 18 |
| Race/Ethnicity, Customized(Participants) | PanOptix Toric Trifocal IOL |
|---|---|
| White | 0 |
| Black or African American | 0 |
| American Indian or Alaska Native | 0 |
| Asian | 54 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Other | 0 |
| Region of Enrollment(participants) | PanOptix Toric Trifocal IOL |
|---|---|
| Australia | 54 |
| Specific Asian Nationality(Participants) | PanOptix Toric Trifocal IOL |
|---|---|
| Chinese | 54 |
| Japanese | 0 |
| Korean | 0 |
| Mongolian | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2020 to primary completion in Dec 2021, 13 months.
Results were first posted in Dec 2022, 1 year after primary completion.
Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 13 months is below that.
Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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