20 and older, any sex, with Aphakia or Corneal Astigmatism. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models CombinedPrimary· Month 3 postoperative, Month 6 postoperative
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
Group
Value
95% CI
All Eyes
0.219
± 0.2388
Month 6 postoperative
Group
Value
95% CI
All Eyes
0.198
± 0.2392
Percentage of Eyes With IOL Rotation Less Than 10 DegreesPrimary· Month 3 postoperative, Month 6 postoperative
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
Group
Value
95% CI
All Eyes
100
Month 6 postoperative
Group
Value
95% CI
All Eyes
100
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)Primary· Month 3 postoperative, Month 6 postoperative
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.
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.
Month 3 postoperative
Group
Value
95% CI
PanOptix Toric Trifocal IOL
0.075
± 0.1068
Month 6 postoperative
Group
Value
95% CI
PanOptix Toric Trifocal IOL
0.089
± 0.1074
Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)Primary· Month 3 postoperative, Month 6 postoperative
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
Group
Value
95% CI
PanOptix Toric Trifocal IOL
0.161
± 0.0924
Month 6 postoperative
Group
Value
95% CI
PanOptix Toric Trifocal IOL
0.139
± 0.0886
Percentage of Eyes With Secondary Surgical Interventions (SSIs), by CategoryPrimary· Up to Month 6 postoperative
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.
SSIs Related to IOL - Due to Optical Properties
Group
Value
95% CI
PanOptix Toric Trifocal IOL - First Eye
0.0
PanOptix Toric Trifocal IOL - Second Eye
0.0
PanOptix Toric Trifocal IOL - All Eyes
0.0
SSIs Related to the IOL - Not Due to Optical Properties
Group
Value
95% CI
PanOptix Toric Trifocal IOL - First Eye
0.0
PanOptix Toric Trifocal IOL - Second Eye
0.0
PanOptix Toric Trifocal IOL - All Eyes
0.0
SSIs Unrelated to the IOL
Group
Value
95% CI
PanOptix Toric Trifocal IOL - First Eye
1.9
PanOptix Toric Trifocal IOL - Second Eye
2.0
PanOptix Toric Trifocal IOL - All Eyes
1.9
Percentage of Subjects With a Severe Visual DisturbancePrimary· Preoperative, Month 3 postoperative, Month 6 postoperative
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 re
Starbursts - Severe
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
11.8
4.4 – 23.9
PanOptix Toric Trifocal IOL - Month 3
17.0
7.6 – 30.8
PanOptix Toric Trifocal IOL - Month 6
14.9
6.2 – 28.3
Halos - Severe
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
9.8
3.3 – 21.4
PanOptix Toric Trifocal IOL - Month 3
6.3
1.3 – 17.2
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Glare - Severe
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
19.6
9.8 – 33.1
PanOptix Toric Trifocal IOL - Month 3
8.3
2.3 – 20.0
PanOptix Toric Trifocal IOL - Month 6
6.5
1.4 – 17.9
Hazy Vision - Severe
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
9.8
3.3 – 21.4
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Blurred Vision - Severe
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
18.0
8.6 – 31.2
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Double Vision - Severe
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
2.0
0.0 – 10.4
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Dark Area - Severe
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
2.0
0.0 – 10.4
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)Primary· Preoperative, Month 3 postoperative, Month 6 postoperative
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 bother
Starbursts - Bothered very much
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
9.8
3.3 – 21.4
PanOptix Toric Trifocal IOL - Month 3
4.2
0.5 – 14.3
PanOptix Toric Trifocal IOL - Month 6
2.1
0.1 – 11.3
Halos - Bothered very much
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
7.8
2.2 – 18.9
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
2.1
0.1 – 11.3
Glare - Bothered very much
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
21.6
11.3 – 35.3
PanOptix Toric Trifocal IOL - Month 3
6.3
1.3 – 17.2
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Hazy Vision - Bothered very much
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
13.7
5.7 – 26.3
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Blurred Vision - Bothered very much
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
20.0
10.0 – 33.7
PanOptix Toric Trifocal IOL - Month 3
2.1
0.1 – 11.1
PanOptix Toric Trifocal IOL - Month 6
2.1
0.1 – 11.3
Double Vision - Bothered very much
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
5.9
1.2 – 16.2
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Dark Area - Bothered very much
Group
Value
95% CI
PanOptix Toric Trifocal IOL - Preoperative
3.9
0.5 – 13.5
PanOptix Toric Trifocal IOL - Month 3
0.0
0.0 – 7.4
PanOptix Toric Trifocal IOL - Month 6
0.0
0.0 – 7.5
Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device EffectsPrimary· Up to Month 6 postoperative
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.
Diabetic retinal oedema
Group
Value
95% CI
PanOptix Toric Trifocal IOL - First Eye
1.9
0.5 – 9.89
PanOptix Toric Trifocal IOL - Second Eye
0.0
0.0 – 6.98
Intra-ocular injection
Group
Value
95% CI
PanOptix Toric Trifocal IOL - First Eye
1.9
0.5 – 9.89
PanOptix Toric Trifocal IOL - Second Eye
0.0
0.0 – 6.98
Iris adhesions
Group
Value
95% CI
PanOptix Toric Trifocal IOL - First Eye
0.0
0.0 – 6.60
PanOptix Toric Trifocal IOL - Second Eye
2.0
0.05 – 10.45
Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device EffectsPrimary· Up to Month 6 postoperative
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.
Coronary arterial stent insertion
Group
Value
95% CI
PanOptix Toric Trifocal IOL
1.9
0.05 – 9.89
Coronary artery disease
Group
Value
95% CI
PanOptix Toric Trifocal IOL
1.9
0.05 – 9.89
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alcon Research
Last refreshed: 30 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04528069.