An interventional study of VIVITY and SYMFONY in Aphakia, sponsored by Alcon Research. Completed at 12 sites in 2 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
VIVITY IOL implanted in the eye during cataract surgery
Device: VIVITY · Procedure: Cataract surgery
SYMFONY IOL implanted in the eye during cataract surgery
Device: SYMFONY · Procedure: Cataract surgery
AT LARA implanted in the eye during cataract surgery
Device: AT LARA · Procedure: Cataract surgery
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
Also known as: AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015
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
Also known as: TECNIS Symfony® Extended Range of Vision IOL Model ZXR00
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
Also known as: AT LARA® extended depth of focus IOL Model 829MP
Cataract removal by routine small incision surgery
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
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)
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
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)
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
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)
Participants were recruited from nine investigative sites located in Australia and three investigative sites located in New Zealand.
| Milestone | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| 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 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 5 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Sick . could not attend visit | 1 | 0 | 0 |
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.
| percentage of subjects | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) | 88.7 | 58.1 | 58.6 |
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 | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) | 53.2 | 55.6 | 35.0 |
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.
| percentage of subjects | VIVITY | SYMFONY | AT LARA |
|---|---|---|---|
| Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) | 79.0 | 55.6 | 38.3 |
Collected over Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/193 (0%) | 0/193 (0%) | 0/193 (0%) |
| VIVITY First Eye | 0/63 (0%) | 1/63 (1.6%) | 7/63 (11.1%) |
| VIVITY Second Eye | 0/63 (0%) | 0/63 (0%) | 7/63 (11.1%) |
| VIVITY Systemic | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) |
| SYMFONY First Eye | 0/65 (0%) | 1/65 (1.5%) | 12/65 (18.5%) |
| SYMFONY Second Eye | 0/65 (0%) | 3/65 (4.6%) | 10/65 (15.4%) |
| SYMFONY Systemic | 0/65 (0%) | 1/65 (1.5%) | 0/65 (0%) |
| AT LARA First Eye | 0/65 (0%) | 3/65 (4.6%) | 17/65 (26.2%) |
| AT LARA Second Eye | 0/63 (0%) | 2/63 (3.2%) | 16/63 (25.4%) |
| AT LARA Systemic | 0/65 (0%) | 4/65 (6.2%) | 0/65 (0%) |
| Event | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Cystoid macular oedemaEye disorders | 0/193 | 0/63 | 0/63 | 0/63 | 0/65 | 2/65 | 0/65 | 1/65 | 1/63 | 0/65 |
| Macular fibrosisEye disorders | 0/193 | 1/63 | 0/63 | 0/63 | 0/65 | 0/65 | 0/65 | 0/65 | 0/63 | 0/65 |
| ParacentesisInvestigations | 0/193 | 0/63 | 0/63 | 0/63 | 0/65 | 0/65 | 0/65 | 1/65 | 1/63 | 0/65 |
| Retinal operationSurgical and medical procedures | 0/193 | 1/63 | 0/63 | 0/63 | 0/65 | 0/65 | 0/65 | 0/65 | 0/63 | 0/65 |
| Atrial fibrillationCardiac disorders | 0/193 | 0/63 | 0/63 | 0/63 | 0/65 | 0/65 | 1/65 | 0/65 | 0/63 | 1/65 |
| Coronary artery diseaseCardiac disorders | 0/193 | 0/63 | 0/63 | 0/63 | 0/65 | 0/65 | 0/65 | 0/65 | 0/63 | 1/65 |
| Halo visionEye disorders | 0/193 | 0/63 | 0/63 | 0/63 | 0/65 | 1/65 | 0/65 | 0/65 | 0/63 | 0/65 |
| Visual impairmentEye disorders | 0/193 | 0/63 | 0/63 | 0/63 | 1/65 | 1/65 | 0/65 | 0/65 | 0/63 | 0/65 |
| FallInjury, poisoning and procedural complications | 0/193 | 0/63 | 0/63 | 0/63 | 0/65 | 0/65 | 0/65 | 0/65 | 0/63 | 1/65 |
| Posterior capsule ruptureInjury, poisoning and procedural complications | 0/193 | 0/63 | 0/63 | 0/63 | 0/65 | 0/65 | 0/65 | 1/65 | 0/63 | 0/65 |
| Event | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Posterior capsule opacificationEye disorders | 0/193 | 7/63 | 7/63 | 0/63 | 12/65 | 10/65 | 0/65 | 17/65 | 16/63 | 0/65 |
All Implanted Analysis Set (AAS): All eyes with successful study IOL implantation in one or more eye.
| Age, Continuous(years) | VIVITY | SYMFONY | AT LARA | Total |
|---|---|---|---|---|
| Mean | 67.2 ± 8.07 | 67.0 ± 9.25 | 66.1 ± 8.60 | 66.7 ± 8.63 |
| Sex: Female, Male(Participants) | VIVITY | SYMFONY | AT LARA | Total |
|---|---|---|---|---|
| Female | 38 | 36 | 40 | 114 |
| Male | 25 | 29 | 25 | 79 |
| Race/Ethnicity, Customized(Participants) | VIVITY | SYMFONY | AT LARA | Total |
|---|---|---|---|---|
| White (Caucasian) | 58 | 47 | 54 | 159 |
| Black | 1 | 2 | 0 | 3 |
| Indigenous or Other Pacific Islander | 0 | 2 | 1 | 3 |
| Asian | 2 | 6 | 7 | 15 |
| Other | 2 | 8 | 3 | 13 |
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