Aphakia
Conditions
Keywords
Cataracts, Extracapsular cataract extraction, IOL, Extended depth of focus, Visual disturbances, Presbyopia, Intraocular lens
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.
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.
Interventions
DEVICEVIVITY
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
DEVICESYMFONY
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
DEVICEAT 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
PROCEDURECataract surgery
Cataract removal by routine small incision surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, New Zealand
Participant flow
Recruitment details
Participants were recruited from nine investigative sites located in Australia and three investigative sites located in New Zealand.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| VIVITY VIVITY IOL implanted in the eye during cataract surgery | 63 |
| SYMFONY SYMFONY IOL implanted in the eye during cataract surgery | 65 |
| AT LARA AT LARA implanted in the eye during cataract surgery | 65 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 5 | 2 |
| Overall Study | Sick . Could not attend visit | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | VIVITY | SYMFONY | AT LARA | Total |
|---|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 8.07 | 67.0 years STANDARD_DEVIATION 9.25 | 66.1 years STANDARD_DEVIATION 8.6 | 66.7 years STANDARD_DEVIATION 8.63 |
| Race/Ethnicity, Customized Asian | 2 Participants | 6 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Indigenous or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 8 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized White (Caucasian) | 58 Participants | 47 Participants | 54 Participants | 159 Participants |
| Sex: Female, Male Female | 38 Participants | 36 Participants | 40 Participants | 114 Participants |
| Sex: Female, Male Male | 25 Participants | 29 Participants | 25 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 193 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 65 | 0 / 65 | 0 / 65 | 0 / 65 | 0 / 63 | 0 / 65 |
| other Total, other adverse events | 0 / 193 | 7 / 63 | 7 / 63 | 0 / 63 | 12 / 65 | 10 / 65 | 0 / 65 | 17 / 65 | 16 / 63 | 0 / 65 |
| serious Total, serious adverse events | 0 / 193 | 1 / 63 | 0 / 63 | 0 / 63 | 1 / 65 | 3 / 65 | 1 / 65 | 3 / 65 | 2 / 63 | 4 / 65 |
Outcome results
Primary
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)
Population: AAS with data at Month 3 postoperative visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIVITY | Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) | 88.7 percentage of subjects |
| SYMFONY | Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) | 58.1 percentage of subjects |
| AT LARA | Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) | 58.6 percentage of subjects |
97.5% CI: [13.34, 46.79]Miettinen-Nurminen
97.5% CI: [12.54, 46.68]Miettinen-Nurminen
Secondary
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)
Population: AAS with data at Month 3 postoperative visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIVITY | Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) | 53.2 percentage of subjects |
| SYMFONY | Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) | 55.6 percentage of subjects |
| AT LARA | Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) | 35.0 percentage of subjects |
97.5% CI: [-21.91, 17.42]Miettinen-Nurminen
97.5% CI: [-12, 27.8]Miettinen-Nurminen
Secondary
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)
Population: AAS with data at Month 3 postoperative visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIVITY | Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) | 79.0 percentage of subjects |
| SYMFONY | Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) | 55.6 percentage of subjects |
| AT LARA | Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) | 38.3 percentage of subjects |
97.5% CI: [4.66, 40.86]Miettinen-Nurminen
97.5% CI: [21.16, 57.22]Miettinen-Nurminen