Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04098367
Collaborator
(none)
222
12
3
20.1
18.5
0.9
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.
Study Design
Study Type:
Interventional
Actual Enrollment
:
222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
Actual Study Start Date
:
Nov 18, 2019
Actual Primary Completion Date
:
May 3, 2021
Actual Study Completion Date
:
Jul 22, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VIVITY VIVITY IOL implanted in the eye during cataract surgery |
Device: VIVITY
Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction
Other Names:
Procedure: Cataract surgery
Cataract removal by routine small incision surgery
|
| Active Comparator: SYMFONY SYMFONY IOL implanted in the eye during cataract surgery |
Device: SYMFONY
Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed
Other Names:
Procedure: Cataract surgery
Cataract removal by routine small incision surgery
|
| Active Comparator: AT LARA AT LARA implanted in the eye during cataract surgery |
Device: AT LARA
Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction
Other Names:
Procedure: Cataract surgery
Cataract removal by routine small incision surgery
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) [Month 3 postoperative (Day 120-180 from second eye surgery)]
QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" 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. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Secondary Outcome Measures
- Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) [Month 3 postoperative (Day 120-180 from second eye surgery)]
Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" 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. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
- Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) [Month 3 postoperative (Day 120-180 from second eye surgery)]
A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" 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. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Eligibility Criteria
Criteria
Ages Eligible for Study:
22 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Planned cataract removal in both eyes.
-
Willing and able to complete all required postoperative visits.
-
Able to understand, read and write English and willing to sign an approved statement of informed consent.
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
-
Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
-
Ocular trauma or ocular surface disease that would affect study measurements.
-
Patients who desire monovision correction.
-
Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigator 8047 | Charlestown | New South Wales | Australia | 2290 |
| 2 | Alcon Investigator 6667 | Sydney | New South Wales | Australia | 2067 |
| 3 | Alcon Investigator 7678 | Sydney | New South Wales | Australia | 2150 |
| 4 | Alcon Investigator 8052 | Eastwood | South Australia | Australia | 5063 |
| 5 | Alcon Investigator 7130 | Hobart | Tasmania | Australia | 7000 |
| 6 | Alcon Investigator 8010 | Essendon | Victoria | Australia | 3040 |
| 7 | Alcon Investigator 7813 | Footscray | Victoria | Australia | 3011 |
| 8 | Alcon Investigator 1702 | Mornington | Victoria | Australia | 3931 |
| 9 | Alcon Investigator 8051 | Murdoch | Western Australia | Australia | 6150 |
| 10 | Alcon Investigator 8056 | Auckland | New Zealand | 1050 | |
| 11 | Alcon Investigator 8050 | Auckland | New Zealand | ||
| 12 | Alcon Investigator 3656 | Wellington | New Zealand | 6011 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, Surgical, Alcon Research, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT04098367
Other Study ID Numbers:
- ILI875-P001
First Posted:
Sep 23, 2019
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Alcon Research
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from nine investigative sites located in Australia and three investigative sites located in New Zealand. |
|---|---|
| Pre-assignment Detail | Of the 222 enrolled, 24 subjects were exited as screen failures prior to randomization. Of the 198 subjects randomized, both eyes from five subjects and second eyes from 2 subjects (i.e., 5 first eyes, 7 second eyes) were discontinued after randomization and prior to attempted implantation. This reporting group includes all randomized and implanted subjects (193). |
| Arm/Group Title | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| Arm/Group Description | VIVITY IOL implanted in the eye during cataract surgery | SYMFONY IOL implanted in the eye during cataract surgery | AT LARA implanted in the eye during cataract surgery |
| Period Title: Overall Study | |||
| STARTED | 63 | 65 | 65 |
| First Eye Implanted | 63 | 65 | 65 |
| Second Eye Implanted | 63 | 65 | 63 |
| COMPLETED | 61 | 60 | 61 |
| NOT COMPLETED | 2 | 5 | 4 |
Baseline Characteristics
| Arm/Group Title | VIVITY | SYMFONY | AT LARA | Total |
|---|---|---|---|---|
| Arm/Group Description | VIVITY IOL implanted in the eye during cataract surgery | SYMFONY IOL implanted in the eye during cataract surgery | AT LARA implanted in the eye during cataract surgery | Total of all reporting groups |
| Overall Participants | 63 | 65 | 65 | 193 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
67.2
(8.07)
|
67.0
(9.25)
|
66.1
(8.60)
|
66.7
(8.63)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
38
60.3%
|
36
55.4%
|
40
61.5%
|
114
59.1%
|
| Male |
25
39.7%
|
29
44.6%
|
25
38.5%
|
79
40.9%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White (Caucasian) |
58
92.1%
|
47
72.3%
|
54
83.1%
|
159
82.4%
|
| Black |
1
1.6%
|
2
3.1%
|
0
0%
|
3
1.6%
|
| Indigenous or Other Pacific Islander |
0
0%
|
2
3.1%
|
1
1.5%
|
3
1.6%
|
| Asian |
2
3.2%
|
6
9.2%
|
7
10.8%
|
15
7.8%
|
| Other |
2
3.2%
|
8
12.3%
|
3
4.6%
|
13
6.7%
|
Outcome Measures
| Title | Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) |
|---|---|
| Description | QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" 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. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. |
| Time Frame | Month 3 postoperative (Day 120-180 from second eye surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| AAS with data at Month 3 postoperative visit |
| Arm/Group Title | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| Arm/Group Description | VIVITY IOL implanted in the eye during cataract surgery | SYMFONY IOL implanted in the eye during cataract surgery | AT LARA implanted in the eye during cataract surgery |
| Measure Participants | 63 | 65 | 63 |
| Number [percentage of subjects] |
88.7
|
58.1
|
58.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIVITY, SYMFONY |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | 30.6 | |
| Confidence Interval |
(2-Sided) 97.5% 13.34 to 46.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | VIVITY minus SYMFONY | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VIVITY, AT LARA |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | 30.1 | |
| Confidence Interval |
(2-Sided) 97.5% 12.54 to 46.68 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | VIVITY minus AT LARA | |
| Title | Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) |
|---|---|
| Description | Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" 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. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. |
| Time Frame | Month 3 postoperative (Day 120-180 from second eye surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| AAS with data at Month 3 postoperative visit |
| Arm/Group Title | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| Arm/Group Description | VIVITY IOL implanted in the eye during cataract surgery | SYMFONY IOL implanted in the eye during cataract surgery | AT LARA implanted in the eye during cataract surgery |
| Measure Participants | 62 | 63 | 60 |
| Number [percentage of subjects] |
53.2
|
55.6
|
35.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIVITY, SYMFONY |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | -2.3 | |
| Confidence Interval |
(2-Sided) 97.5% -21.91 to 17.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | VIVITY minus SYMFONY | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VIVITY, AT LARA |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | 8.2 | |
| Confidence Interval |
(2-Sided) 97.5% -12.00 to 27.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | VIVITY minus AT LARA | |
| Title | Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) |
|---|---|
| Description | A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" 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. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. |
| Time Frame | Month 3 postoperative (Day 120-180 from second eye surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| AAS with data at Month 3 postoperative visit |
| Arm/Group Title | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| Arm/Group Description | VIVITY IOL implanted in the eye during cataract surgery | SYMFONY IOL implanted in the eye during cataract surgery | AT LARA implanted in the eye during cataract surgery |
| Measure Participants | 62 | 63 | 60 |
| Number [percentage of subjects] |
79.0
|
55.6
|
38.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VIVITY, SYMFONY |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | 23.5 | |
| Confidence Interval |
(2-Sided) 97.5% 4.66 to 40.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | VIVITY minus SYMFONY | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | VIVITY, AT LARA |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentage |
| Estimated Value | 40.7 | |
| Confidence Interval |
(2-Sided) 97.5% 21.16 to 57.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | VIVITY minus AT LARA | |
Adverse Events
| Time Frame | Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes. | |||||||||||||||||||
| Arm/Group Title | Pretreatment | VIVITY First Eye | VIVITY Second Eye | VIVITY Systemic | SYMFONY First Eye | SYMFONY Second Eye | SYMFONY Systemic | AT LARA First Eye | AT LARA Second Eye | AT LARA Systemic | ||||||||||
| Arm/Group Description | All subjects prior to with attempted implantation with any IOL (successful or aborted implant) | All eyes that had contact with the VIVITY IOL (successful or aborted implant) | All eyes that had contact with the VIVITY IOL (successful or aborted implant) | All subjects that had contact with the VIVITY IOL (successful or aborted implant) | All eyes that had contact with the SYMFONY IOL (successful or aborted implant) | All eyes that had contact with the SYMFONY IOL (successful or aborted implant) | All subjects that had contact with the SYMFONY IOL (successful or aborted implant) | All eyes that had contact with the AT LARA IOL (successful or aborted implant) | All eyes that had contact with the AT LARA IOL (successful or aborted implant) | All subjects that had contact with the AT LARA IOL (successful or aborted implant) | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Pretreatment | VIVITY First Eye | VIVITY Second Eye | VIVITY Systemic | SYMFONY First Eye | SYMFONY Second Eye | SYMFONY Systemic | AT LARA First Eye | AT LARA Second Eye | AT LARA Systemic | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/193 (0%) | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) | 0/63 (0%) | 0/65 (0%) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Pretreatment | VIVITY First Eye | VIVITY Second Eye | VIVITY Systemic | SYMFONY First Eye | SYMFONY Second Eye | SYMFONY Systemic | AT LARA First Eye | AT LARA Second Eye | AT LARA Systemic | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/193 (0%) | 1/63 (1.6%) | 0/63 (0%) | 0/63 (0%) | 1/65 (1.5%) | 3/65 (4.6%) | 1/65 (1.5%) | 3/65 (4.6%) | 2/63 (3.2%) | 4/65 (6.2%) | ||||||||||
| Cardiac disorders | ||||||||||||||||||||
| Atrial fibrillation | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| Coronary artery disease | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| Eye disorders | ||||||||||||||||||||
| Cystoid macular oedema | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 2/65 (3.1%) | 2 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/65 (0%) | 0 |
| Halo vision | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
| Macular fibrosis | 0/193 (0%) | 0 | 1/63 (1.6%) | 1 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
| Visual impairment | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 | 1/65 (1.5%) | 1 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Fall | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| Posterior capsule rupture | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
| Investigations | ||||||||||||||||||||
| Intraocular pressure increased | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
| Paracentesis | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 1/63 (1.6%) | 1 | 0/65 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||
| Carotid artery aneurysm | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| Surgical and medical procedures | ||||||||||||||||||||
| Angioplasty | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| Lens extraction | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
| Parathyroidectomy | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| Retinal operation | 0/193 (0%) | 0 | 1/63 (1.6%) | 1 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
| Vitrectomy | 0/193 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/63 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 0/65 (0%) | 0 | 1/65 (1.5%) | 1 | 0/63 (0%) | 0 | 0/65 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Pretreatment | VIVITY First Eye | VIVITY Second Eye | VIVITY Systemic | SYMFONY First Eye | SYMFONY Second Eye | SYMFONY Systemic | AT LARA First Eye | AT LARA Second Eye | AT LARA Systemic | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/193 (0%) | 7/63 (11.1%) | 7/63 (11.1%) | 0/63 (0%) | 12/65 (18.5%) | 10/65 (15.4%) | 0/65 (0%) | 17/65 (26.2%) | 16/63 (25.4%) | 0/65 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Posterior capsule opacification | 0/193 (0%) | 0 | 7/63 (11.1%) | 7 | 7/63 (11.1%) | 7 | 0/63 (0%) | 0 | 12/65 (18.5%) | 12 | 10/65 (15.4%) | 10 | 0/65 (0%) | 0 | 17/65 (26.2%) | 19 | 16/63 (25.4%) | 17 | 0/65 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Sr. CDMA Project Lead, Surgical |
|---|---|
| Organization | Alcon Research, LLC |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT04098367
Other Study ID Numbers:
- ILI875-P001
First Posted:
Sep 23, 2019
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022