Cataract
Conditions
Brief summary
The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.
Detailed description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
Interventions
DEVICEVivity Extended Depth of Focus intraocular lens (IOL)
Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
Sponsors
Newsom Eye & Laser Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL * Meet the requirements for on-label implantation of the EDF IOL * Gender: Males and Females. * Age: 40 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. * Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or toric IOL. * Have 20/32 (0.2 logMAR) or better potential acuity in both eyes
Exclusion criteria
* • Irregular astigmatism (e.g. keratoconus) * Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye) * Monocular status (e.g. amblyopia) * Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty) * Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) * Diabetic retinopathy * Macular pathology (e.g. ARMD, ERM) * History of retinal detachment * Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. * Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Near Visual Acuity | 3 months postop | binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Intermediate Visual Acuity | 3 months postop | Bilateral uncorrected visual acuity at 66 cm |
| Uncorrected Near Visual Acuity | 3 months postop | Bilateral uncorrected near visual acuity at 40 cm |
| Corrected Distance Visual Acuity | 3 months postop | Bliateral corrected distance visual acuity |
| Distance Corrected Intermediate Visual Acuity | 3 months postop | Bliateral distance corrected visual acuity at 66 cm |
| Prediction Accuracy | 3 months postop | Percentage of eyes with postoperative refractive accuracy within 0.5D of target |
| Uncorrected Distance Visual Acuity | 3 months postop | Bilateral uncorrected distance visual acuity |
| Patient Spectacle Independence | 3 months postop | Patients reporting rarely or never needing glasses overall |
| Number of Participants Rating Frequency of Visual Disturbances as Never or Rarely | 3 months postop | This is the frequency of subjects responding, Never or Rarely to a question about the frequency of glare, halos and starbursts. |
| Manifest Refraction | 3 months postop | Manifest refraction (residual spherical equivalent refraction) |
| Residual Cylinder | 3 months | Residual refractive cylinder after surgery |
| Spectacle Independence | 3 months postop | Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - a little of the time or none of the time) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vivity Monovision Group Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Unrelated illness | 1 |
Baseline characteristics
| Characteristic | Vivity Monovision Group | — |
|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 5.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 33 participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Binocular Near Visual Acuity
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivity Monovision Group | Binocular Near Visual Acuity | 0.14 logMAR | Standard Deviation 0.1 |
Secondary
Corrected Distance Visual Acuity
Bliateral corrected distance visual acuity
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivity Monovision Group | Corrected Distance Visual Acuity | 0.01 logMAR | Standard Deviation 0.08 |
Secondary
Distance Corrected Intermediate Visual Acuity
Bliateral distance corrected visual acuity at 66 cm
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivity Monovision Group | Distance Corrected Intermediate Visual Acuity | 0.02 logMAR | Standard Deviation 0.06 |
Secondary
Manifest Refraction
Manifest refraction (residual spherical equivalent refraction)
Time frame: 3 months postop
Population: Each subject had 1 eye targeted for plano, and one eye targeted for myopia. So, each row includes 33 eyes of 33 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivity Monovision Group | Manifest Refraction | Eyes targeted for plano | .01 diopters | Standard Deviation 0.31 |
| Vivity Monovision Group | Manifest Refraction | Eyes targeted for myopia | -.74 diopters | Standard Deviation 0.39 |
Secondary
Number of Participants Rating Frequency of Visual Disturbances as Never or Rarely
This is the frequency of subjects responding, Never or Rarely to a question about the frequency of glare, halos and starbursts.
Time frame: 3 months postop
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vivity Monovision Group | Number of Participants Rating Frequency of Visual Disturbances as Never or Rarely | Glare frequency never or 'rarely | 19 Participants |
| Vivity Monovision Group | Number of Participants Rating Frequency of Visual Disturbances as Never or Rarely | Halos frequency never or rarely | 18 Participants |
| Vivity Monovision Group | Number of Participants Rating Frequency of Visual Disturbances as Never or Rarely | Starbursts frequency never or rarely | 13 Participants |
Secondary
Patient Spectacle Independence
Patients reporting rarely or never needing glasses overall
Time frame: 3 months postop
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vivity Monovision Group | Patient Spectacle Independence | 23 Participants |
Secondary
Prediction Accuracy
Percentage of eyes with postoperative refractive accuracy within 0.5D of target
Time frame: 3 months postop
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vivity Monovision Group | Prediction Accuracy | 56 Eyes |
Secondary
Residual Cylinder
Residual refractive cylinder after surgery
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivity Monovision Group | Residual Cylinder | 0.42 diopters | Standard Deviation 0.3 |
Secondary
Spectacle Independence
Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - a little of the time or none of the time)
Time frame: 3 months postop
Population: All subjects who completed 3M PRSIQ questionnaire successfully
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vivity Monovision Group | Spectacle Independence | 26 Participants |
Secondary
Uncorrected Distance Visual Acuity
Bilateral uncorrected distance visual acuity
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivity Monovision Group | Uncorrected Distance Visual Acuity | 0.02 logMAR | Standard Deviation 0.09 |
Secondary
Uncorrected Intermediate Visual Acuity
Bilateral uncorrected visual acuity at 66 cm
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivity Monovision Group | Uncorrected Intermediate Visual Acuity | 0 logMAR | Standard Deviation 0.07 |
Secondary
Uncorrected Near Visual Acuity
Bilateral uncorrected near visual acuity at 40 cm
Time frame: 3 months postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivity Monovision Group | Uncorrected Near Visual Acuity | 0.12 logMAR | Standard Deviation 0.1 |