Aphakia
Conditions
Keywords
Cataract, Intraocular lens
Brief summary
This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.
Detailed description
Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.
Interventions
DEVICEClareon Vivity/Vivity Toric Extended Vision IOL
Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
DEVICEClareon Monofocal/Clareon Toric IOL
Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will be masked to the IOLs that have been previously implanted in the subject until the end of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Understand and sign an approved Informed Consent form * Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion. * Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia. * Clinically significant PCO (posterior capsule opacification) affecting vision. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) | Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint. |
| Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) | Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) | Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 40 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. |
| Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) | The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The percentage was calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. A higher percentage is a better outcome. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Lead, Surgical CRD
Alcon Research, LLC
Participant flow
Recruitment details
Participants were enrolled at 7 investigative sites located in the United States.
Pre-assignment details
Of the 155 enrolled, 5 participants were exited as screen failures. This reporting group includes all eligible subjects (150).
Participants by arm
| Arm | Count |
|---|---|
| Clareon Vivity/Vivity Toric Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation | 73 |
| Clareon Monofocal/Clareon Toric Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation | 76 |
| Total | 149 |
Baseline characteristics
| Characteristic | Total | Clareon Vivity/Vivity Toric | Clareon Monofocal/Clareon Toric |
|---|---|---|---|
| Age, Continuous | 70.0 years STANDARD_DEVIATION 8.1 | 68.4 years STANDARD_DEVIATION 8.92 | 71.5 years STANDARD_DEVIATION 6.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 148 Participants | 73 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 131 Participants | 68 Participants | 63 Participants |
| Region of Enrollment United States | 149 participants | 73 participants | 76 participants |
| Sex: Female, Male Female | 88 Participants | 42 Participants | 46 Participants |
| Sex: Female, Male Male | 61 Participants | 31 Participants | 30 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 73 | 0 / 73 | 0 / 76 | 0 / 76 | 0 / 76 |
| other Total, other adverse events | 0 / 73 | 0 / 73 | 0 / 73 | 0 / 76 | 0 / 76 | 0 / 76 |
| serious Total, serious adverse events | 0 / 73 | 0 / 73 | 0 / 73 | 0 / 76 | 0 / 76 | 0 / 76 |
Outcome results
Primary
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Population: FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon Vivity/Vivity Toric | Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | -0.028 logMAR | Standard Deviation 0.1165 |
| Clareon Monofocal/Clareon Toric | Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | -0.062 logMAR | Standard Deviation 0.0847 |
95% CI: [0.001, 0.067]
Primary
Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Population: FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon Vivity/Vivity Toric | Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 0.035 logMAR | Standard Deviation 0.0788 |
| Clareon Monofocal/Clareon Toric | Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 0.126 logMAR | Standard Deviation 0.1033 |
p-value: <0.00195% CI: [-0.12, -0.061]t-test, 1 sided
Secondary
Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 40 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Population: FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clareon Vivity/Vivity Toric | Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 0.205 logMAR | Standard Deviation 0.1008 |
| Clareon Monofocal/Clareon Toric | Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 0.334 logMAR | Standard Deviation 0.141 |
p-value: <0.00195% CI: [-0.169, -0.089]t-test, 1 sided
Secondary
Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, Overall, in the past 7 days, how often did you need to wear eyeglasses to see? The percentage was calculated as (# of subjects responding Never) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. A higher percentage is a better outcome.
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Population: FAS with requisite data at visit. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clareon Vivity/Vivity Toric | Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 21.4 percentage of participants |
| Clareon Monofocal/Clareon Toric | Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | 4.1 percentage of participants |
Miettinen-Nurminen