Trial Outcomes & Findings for Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population (NCT NCT04528069)
NCT ID: NCT04528069
Last Updated: 2022-12-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Preoperative, Month 3 postoperative, Month 6 postoperative
Results posted on
2022-12-30
Participant Flow
Subjects were recruited from 4 investigative sites located in Australia.
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.
Unit of analysis: eyes
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
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54 105
|
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Overall Study
First Eye Implanted
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54 54
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|
Overall Study
Second Eye Implanted
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51 51
|
|
Overall Study
COMPLETED
|
50 97
|
|
Overall Study
NOT COMPLETED
|
4 8
|
Reasons for withdrawal
| Measure |
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).
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|---|---|
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Overall Study
Adverse Event
|
1
|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Patient Unable to Come
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1
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Overall Study
Patient Unable to Attend
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1
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Baseline Characteristics
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Baseline characteristics by cohort
| Measure |
PanOptix Toric Trifocal IOL
n=54 Participants
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).
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|---|---|
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Age, Continuous
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66.8 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
|
Sex: Female, Male
Female
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36 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
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0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
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54 Participants
n=5 Participants
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Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other
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0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
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54 participants
n=5 Participants
|
|
Specific Asian Nationality
Chinese
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54 Participants
n=5 Participants
|
|
Specific Asian Nationality
Japanese
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0 Participants
n=5 Participants
|
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Specific Asian Nationality
Korean
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0 Participants
n=5 Participants
|
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Specific Asian Nationality
Mongolian
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Month 3 postoperative, Month 6 postoperativePopulation: All-Implanted Analysis Set (AAS): All eyes with successful IOL implantation with at least one post-operative visit and data at study visit
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.
Outcome measures
| Measure |
All Eyes
n=98 eyes
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
|
PanOptix Toric Trifocal IOL - Second Eye
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
|
PanOptix Toric Trifocal IOL - All Eyes
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
|
|---|---|---|---|
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Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined
Month 3 postoperative
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0.219 diopter
Standard Deviation 0.2388
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—
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—
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|
Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined
Month 6 postoperative
|
0.198 diopter
Standard Deviation 0.2392
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—
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—
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PRIMARY outcome
Timeframe: Month 3 postoperative, Month 6 postoperativePopulation: AAS
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.
Outcome measures
| Measure |
All Eyes
n=98 eyes
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
|
PanOptix Toric Trifocal IOL - Second Eye
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
|
PanOptix Toric Trifocal IOL - All Eyes
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
|
|---|---|---|---|
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Percentage of Eyes With IOL Rotation Less Than 10 Degrees
Month 3 postoperative
|
100 percentage of eyes
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—
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—
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Percentage of Eyes With IOL Rotation Less Than 10 Degrees
Month 6 postoperative
|
100 percentage of eyes
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3 postoperative, Month 6 postoperativePopulation: AAS
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.
Outcome measures
| Measure |
All Eyes
n=48 Participants
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
|
PanOptix Toric Trifocal IOL - Second Eye
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
|
PanOptix Toric Trifocal IOL - All Eyes
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
|
|---|---|---|---|
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Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
Month 3 postoperative
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0.043 logMAR
Standard Deviation 0.0881
|
—
|
—
|
|
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
Month 6 postoperative
|
0.022 logMAR
Standard Deviation 0.0810
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—
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—
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PRIMARY outcome
Timeframe: Month 3 postoperative, Month 6 postoperativePopulation: AAS
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.
Outcome measures
| Measure |
All Eyes
n=48 Participants
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
|
PanOptix Toric Trifocal IOL - Second Eye
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
|
PanOptix Toric Trifocal IOL - All Eyes
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
|
|---|---|---|---|
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Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Month 3 postoperative
|
0.075 logMAR
Standard Deviation 0.1068
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—
|
—
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|
Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Month 6 postoperative
|
0.089 logMAR
Standard Deviation 0.1074
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3 postoperative, Month 6 postoperativePopulation: AAS
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.
Outcome measures
| Measure |
All Eyes
n=48 Participants
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
|
PanOptix Toric Trifocal IOL - Second Eye
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
|
PanOptix Toric Trifocal IOL - All Eyes
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
|
|---|---|---|---|
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Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)
Month 3 postoperative
|
0.161 logMAR
Standard Deviation 0.0924
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—
|
—
|
|
Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)
Month 6 postoperative
|
0.139 logMAR
Standard Deviation 0.0886
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—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 6 postoperativePopulation: Safety Analysis Set (SAS): All eyes with attempted IOL implantation, successful or aborted after contact with the eye, and data at study visit
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.
Outcome measures
| Measure |
All Eyes
n=54 eyes
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
|
PanOptix Toric Trifocal IOL - Second Eye
n=51 eyes
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
|
PanOptix Toric Trifocal IOL - All Eyes
n=105 eyes
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
|
|---|---|---|---|
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Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category
SSIs Related to IOL - Due to Optical Properties
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category
SSIs Related to the IOL - Not Due to Optical Properties
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category
SSIs Unrelated to the IOL
|
1.9 percentage of eyes
|
2.0 percentage of eyes
|
1.9 percentage of eyes
|
PRIMARY outcome
Timeframe: Preoperative, Month 3 postoperative, Month 6 postoperativePopulation: SAS
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.
Outcome measures
| Measure |
All Eyes
n=51 Participants
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
|
PanOptix Toric Trifocal IOL - Second Eye
n=48 Participants
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
|
PanOptix Toric Trifocal IOL - All Eyes
n=47 Participants
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
|
|---|---|---|---|
|
Percentage of Subjects With a Severe Visual Disturbance
Starbursts - Severe
|
11.8 percentage of participants
Interval 4.4 to 23.9
|
17.0 percentage of participants
Interval 7.6 to 30.8
|
14.9 percentage of participants
Interval 6.2 to 28.3
|
|
Percentage of Subjects With a Severe Visual Disturbance
Halos - Severe
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9.8 percentage of participants
Interval 3.3 to 21.4
|
6.3 percentage of participants
Interval 1.3 to 17.2
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0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Subjects With a Severe Visual Disturbance
Glare - Severe
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19.6 percentage of participants
Interval 9.8 to 33.1
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8.3 percentage of participants
Interval 2.3 to 20.0
|
6.5 percentage of participants
Interval 1.4 to 17.9
|
|
Percentage of Subjects With a Severe Visual Disturbance
Hazy Vision - Severe
|
9.8 percentage of participants
Interval 3.3 to 21.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Subjects With a Severe Visual Disturbance
Blurred Vision - Severe
|
18.0 percentage of participants
Interval 8.6 to 31.2
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Subjects With a Severe Visual Disturbance
Double Vision - Severe
|
2.0 percentage of participants
Interval 0.0 to 10.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Subjects With a Severe Visual Disturbance
Dark Area - Severe
|
2.0 percentage of participants
Interval 0.0 to 10.4
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
PRIMARY outcome
Timeframe: Preoperative, Month 3 postoperative, Month 6 postoperativePopulation: SAS
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.
Outcome measures
| Measure |
All Eyes
n=51 Participants
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
|
PanOptix Toric Trifocal IOL - Second Eye
n=48 Participants
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
|
PanOptix Toric Trifocal IOL - All Eyes
n=47 Participants
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
|
|---|---|---|---|
|
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Starbursts - Bothered very much
|
9.8 percentage of participants
Interval 3.3 to 21.4
|
4.2 percentage of participants
Interval 0.5 to 14.3
|
2.1 percentage of participants
Interval 0.1 to 11.3
|
|
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Halos - Bothered very much
|
7.8 percentage of participants
Interval 2.2 to 18.9
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
2.1 percentage of participants
Interval 0.1 to 11.3
|
|
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Glare - Bothered very much
|
21.6 percentage of participants
Interval 11.3 to 35.3
|
6.3 percentage of participants
Interval 1.3 to 17.2
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Hazy Vision - Bothered very much
|
13.7 percentage of participants
Interval 5.7 to 26.3
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Blurred Vision - Bothered very much
|
20.0 percentage of participants
Interval 10.0 to 33.7
|
2.1 percentage of participants
Interval 0.1 to 11.1
|
2.1 percentage of participants
Interval 0.1 to 11.3
|
|
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Double Vision - Bothered very much
|
5.9 percentage of participants
Interval 1.2 to 16.2
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Dark Area - Bothered very much
|
3.9 percentage of participants
Interval 0.5 to 13.5
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
0.0 percentage of participants
Interval 0.0 to 7.5
|
PRIMARY outcome
Timeframe: Up to Month 6 postoperativePopulation: SAS
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.
Outcome measures
| Measure |
All Eyes
n=54 Participants
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
|
PanOptix Toric Trifocal IOL - Second Eye
n=51 Participants
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
|
PanOptix Toric Trifocal IOL - All Eyes
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
|
|---|---|---|---|
|
Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects
Diabetic retinal oedema
|
1.9 percentage of participants
Interval 0.5 to 9.89
|
0.0 percentage of participants
Interval 0.0 to 6.98
|
—
|
|
Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects
Intra-ocular injection
|
1.9 percentage of participants
Interval 0.5 to 9.89
|
0.0 percentage of participants
Interval 0.0 to 6.98
|
—
|
|
Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects
Iris adhesions
|
0.0 percentage of participants
Interval 0.0 to 6.6
|
2.0 percentage of participants
Interval 0.05 to 10.45
|
—
|
PRIMARY outcome
Timeframe: Up to Month 6 postoperativePopulation: SAS
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.
Outcome measures
| Measure |
All Eyes
n=54 Participants
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
|
PanOptix Toric Trifocal IOL - Second Eye
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
|
PanOptix Toric Trifocal IOL - All Eyes
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
|
|---|---|---|---|
|
Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects
Coronary arterial stent insertion
|
1.9 percentage of participants
Interval 0.05 to 9.89
|
—
|
—
|
|
Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects
Coronary artery disease
|
1.9 percentage of participants
Interval 0.05 to 9.89
|
—
|
—
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PanOptix Toric First Eye
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
PanOptix Toric Second Eye
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PanOptix Toric Systemic
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment
n=54 participants at risk
Events reported in this group occurred prior to attempted implantation with the test article
|
PanOptix Toric First Eye
n=54 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye
|
PanOptix Toric Second Eye
n=51 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye
|
PanOptix Toric Systemic
n=54 participants at risk
Events reported in this group occurred after attempted implantation with the test article
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/54 • 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.
|
0.00%
0/54 • 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.
|
0.00%
0/51 • 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.
|
1.9%
1/54 • Number of events 1 • 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.
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/54 • 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.
|
1.9%
1/54 • Number of events 1 • 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.
|
0.00%
0/51 • 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.
|
0.00%
0/54 • 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.
|
|
Eye disorders
Iris adhesions
|
0.00%
0/54 • 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.
|
0.00%
0/54 • 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.
|
2.0%
1/51 • Number of events 2 • 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.
|
0.00%
0/54 • 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.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/54 • 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.
|
0.00%
0/54 • 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.
|
0.00%
0/51 • 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.
|
1.9%
1/54 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Intra-ocular injection
|
0.00%
0/54 • 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.
|
1.9%
1/54 • Number of events 1 • 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.
|
0.00%
0/51 • 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.
|
0.00%
0/54 • 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.
|
Other adverse events
| Measure |
Pretreatment
n=54 participants at risk
Events reported in this group occurred prior to attempted implantation with the test article
|
PanOptix Toric First Eye
n=54 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye
|
PanOptix Toric Second Eye
n=51 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye
|
PanOptix Toric Systemic
n=54 participants at risk
Events reported in this group occurred after attempted implantation with the test article
|
|---|---|---|---|---|
|
Eye disorders
Corneal erosion
|
0.00%
0/54 • 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.
|
5.6%
3/54 • Number of events 4 • 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.
|
3.9%
2/51 • Number of events 2 • 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.
|
0.00%
0/54 • 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.
|
|
Eye disorders
Dry eye
|
0.00%
0/54 • 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.
|
5.6%
3/54 • Number of events 3 • 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.
|
3.9%
2/51 • Number of events 2 • 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.
|
0.00%
0/54 • 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.
|
Additional Information
Director of Clinical Projects, Surgical
Alcon Research, LLC
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER