Cataract
Conditions
Keywords
EDOF IOL Vivity
Brief summary
The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.
Detailed description
This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.
Interventions
DEVICEVivity
Vivity intraocular lens (IOL)
Sponsors
Sengi
Dr. James J. Wiens Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Inclusion Criteria: * Undergoing uncomplicated bilateral cataract surgery with IOL implantation. * Gender: Males and Females. * Age: 50 years or older. * Willing and able to provide written informed consent for participation in the study. * Willing and able to comply with scheduled visits and other study procedures. * Motivated for greater degree of spectacle independence vs monofocal IOL. * Axial length ≥24.5mm in both eyes. * Planned cataract removal by femtosecond laser.
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Uncorrected Distance Visual Acuity (logMAR) | 3 months postoperatively | Binocular uncorrected distance visual acuity (logMAR) |
| Binocular Uncorrected Intermediate Visual Acuity (logMAR) | 3 months postoperatively | Binocular uncorrected intermediate visual acuity (logMAR) |
| Binocular Uncorrected Near Visual Acuity (logMAR) | 3 months postoperatively | Binocular uncorrected near visual acuity (logMAR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity (logMAR) | 3 months postoperatively | Binocular distance corrected intermediate visual acuity (logMAR) |
| Binocular Distance Corrected Near Visual Acuity (logMAR) | 3 months postoperatively | Binocular distance corrected near visual acuity (logMAR) |
| Monocular Corrected Distance Visual Acuity (logMAR) | 3 months postoperatively | Monocular corrected distance visual acuity (logMAR) |
| Monocular Distance Corrected Intermediate Visual Acuity (logMAR) | 3 months postoperatively | Monocular distance corrected intermediate visual acuity (logMAR) |
| Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR) | 3 months postoperatively | Binocular distance-corrected low contrast distance visual acuity (logMAR) |
| Manifest Refraction Spherical Equivalent | 3 months postoperatively | Manifest refraction spherical equivalent |
| Questionnaire | 3 months postoperatively | Questionnaire for visual disturbance scores (QUVID) |
| Percentage of Participants With Spectacle Independence | 3 months | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding Never or Rarely) divided by (# of subjects) times 100. A higher percentage is a better outcome. |
| Monocular Distance Corrected Near Visual Acuity (logMAR) | 3 months postoperatively | Monocular distance corrected near visual acuity (logMAR) |
| Prediction Error | 3 months postoperatively | Percentage of eyes with absolute prediction error of 0.5D or less |
| Binocular Corrected Distance Visual Acuity (logMAR) | 3 months postoperatively | Binocular corrected distance visual acuity (logMAR) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Implantation of the Vivity IOL Vivity intraocular lens (IOL)
Vivity: Vivity intraocular lens (IOL) | 20 |
| Bilateral Implantation of the Vivity IOL Vivity intraocular lens (IOL)
Vivity: Vivity intraocular lens (IOL) | 40 |
| Total | 60 |
Baseline characteristics
| Characteristic | Bilateral Implantation of the Vivity IOL |
|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Binocular Uncorrected Distance Visual Acuity (logMAR)
Binocular uncorrected distance visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Binocular Uncorrected Distance Visual Acuity (logMAR) | -0.1 logMAR | Standard Deviation 0.06 |
Primary
Binocular Uncorrected Intermediate Visual Acuity (logMAR)
Binocular uncorrected intermediate visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Binocular Uncorrected Intermediate Visual Acuity (logMAR) | 0.01 logMAR | Standard Deviation 0.08 |
Primary
Binocular Uncorrected Near Visual Acuity (logMAR)
Binocular uncorrected near visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Binocular Uncorrected Near Visual Acuity (logMAR) | 0.21 logMAR | Standard Deviation 0.11 |
Secondary
Binocular Corrected Distance Visual Acuity (logMAR)
Binocular corrected distance visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Binocular Corrected Distance Visual Acuity (logMAR) | -0.14 logMAR | Standard Deviation 0.06 |
Secondary
Binocular Distance Corrected Intermediate Visual Acuity (logMAR)
Binocular distance corrected intermediate visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Binocular Distance Corrected Intermediate Visual Acuity (logMAR) | -0.02 logMAR | Standard Deviation 0.06 |
Secondary
Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)
Binocular distance-corrected low contrast distance visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR) | 0.05 logMAR | Standard Deviation 0.08 |
Secondary
Binocular Distance Corrected Near Visual Acuity (logMAR)
Binocular distance corrected near visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Binocular Distance Corrected Near Visual Acuity (logMAR) | 0.18 logMAR | Standard Deviation 0.1 |
Secondary
Manifest Refraction Spherical Equivalent
Manifest refraction spherical equivalent
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Manifest Refraction Spherical Equivalent | 0.25 diopter (D) | Standard Deviation 0.37 |
Secondary
Monocular Corrected Distance Visual Acuity (logMAR)
Monocular corrected distance visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Monocular Corrected Distance Visual Acuity (logMAR) | -0.09 logMAR | Standard Deviation 0.05 |
Secondary
Monocular Distance Corrected Intermediate Visual Acuity (logMAR)
Monocular distance corrected intermediate visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Monocular Distance Corrected Intermediate Visual Acuity (logMAR) | 0.05 logMAR | Standard Deviation 0.09 |
Secondary
Monocular Distance Corrected Near Visual Acuity (logMAR)
Monocular distance corrected near visual acuity (logMAR)
Time frame: 3 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Monocular Distance Corrected Near Visual Acuity (logMAR) | 0.32 logMAR | Standard Deviation 0.15 |
Secondary
Percentage of Participants With Spectacle Independence
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding Never or Rarely) divided by (# of subjects) times 100. A higher percentage is a better outcome.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Percentage of Participants With Spectacle Independence | Spectacle independence distance (overall) | 19 Participants |
| Bilateral Implantation of the Vivity IOL | Percentage of Participants With Spectacle Independence | Spectcle independence intermediate (overall) | 18 Participants |
| Bilateral Implantation of the Vivity IOL | Percentage of Participants With Spectacle Independence | Spectacle independence near (overall) | 8 Participants |
Secondary
Prediction Error
Percentage of eyes with absolute prediction error of 0.5D or less
Time frame: 3 months postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Bilateral Implantation of the Vivity IOL | Prediction Error | 35 Eyes |
Secondary
Questionnaire
Questionnaire for visual disturbance scores (QUVID)
Time frame: 3 months postoperatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bilateral Implantation of the Vivity IOL | Questionnaire | Bothered quite a bit or Bothered very much by double vision | 0 Participants |
| Bilateral Implantation of the Vivity IOL | Questionnaire | Bothered quite a bit or Bothered very much by starbursts | 2 Participants |
| Bilateral Implantation of the Vivity IOL | Questionnaire | Bothered quite a bit or Bothered very much by halos | 0 Participants |
| Bilateral Implantation of the Vivity IOL | Questionnaire | Bothered quite a bit or Bothered very much by glare | 2 Participants |
| Bilateral Implantation of the Vivity IOL | Questionnaire | Bothered quite a bit or Bothered very much by haze | 1 Participants |
| Bilateral Implantation of the Vivity IOL | Questionnaire | Bothered quite a bit or Bothered very much by blurred vision | 0 Participants |
| Bilateral Implantation of the Vivity IOL | Questionnaire | Bothered quite a bit or Bothered very much by dark area | 0 Participants |