Cataracts
Conditions
Keywords
Intraocular Lens, Monofocal, Multifocal
Brief summary
The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.
Detailed description
Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.
Interventions
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bilateral cataracts * Willing and able to complete all required postoperative visits * Calculated lens power within the available supply range * Planned cataract removal by phacoemulsification * Potential postoperative visual acuity of 0.2 logMAR or better in both eyes * Preoperative astigmatism less than 1.0 diopter * Clear intraocular media other than cataract in study eyes * Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR * Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Previous refractive surgery * Inflammation or edema of the cornea * Optic nerve atrophy * Pregnancy * Current participation in another investigational drug or device study * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mesopic Contrast Sensitivity With Glare at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. |
| Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 | Day 120-180 from second eye implantation | Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye. |
| Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Day 0 first operative eye visit, up to Day 120-180 from second eye implantation | Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL. |
| Photopic Contrast Sensitivity Without Glare at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. |
| Photopic Contrast Sensitivity With Glare at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. |
| Mesopic Contrast Sensitivity Without Glare at Day 120-180 | Day 120-180 from second eye implantation | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 | Day 120-180 from second eye implantation | VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye. |
| Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Day 120-180 from second eye implantation | Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses overall? |
| Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Day 120-180 from second eye implantation | Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses for seeing objects up close? |
| Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 | Day 120-180 from second eye implantation | VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye. |
Participant flow
Recruitment details
Participants were recruited and enrolled from 15 investigative sites located in the United States.
Pre-assignment details
Of the 409 participants enrolled, 80 were discontinued prior to randomization as screen failures and 9 were discontinued after randomization prior to implantation. This reporting group includes all participants with successful IOL implantation in at least 1 eye (320).
Participants by arm
| Arm | Count |
|---|---|
| Multifocal IOL AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] | 155 |
| Monofocal IOL AcrySof® IQ Monofocal IOL Model SN60WF | 165 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Monofocal IOL | Multifocal IOL | Total |
|---|---|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 8.27 | 68.7 years STANDARD_DEVIATION 9.64 | 69.0 years STANDARD_DEVIATION 8.95 |
| Age, Customized 20-29 years | 0 participants | 1 participants | 1 participants |
| Age, Customized 30-39 years | 0 participants | 2 participants | 2 participants |
| Age, Customized 40-49 years | 3 participants | 2 participants | 5 participants |
| Age, Customized 50-59 years | 12 participants | 18 participants | 30 participants |
| Age, Customized 60-69 years | 62 participants | 53 participants | 115 participants |
| Age, Customized 70-79 years | 71 participants | 65 participants | 136 participants |
| Age, Customized ≥80 years | 17 participants | 14 participants | 31 participants |
| Region of Enrollment United States | 165 participants | 155 participants | 320 participants |
| Sex: Female, Male Female | 97 Participants | 96 Participants | 193 Participants |
| Sex: Female, Male Male | 68 Participants | 59 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 409 | 0 / 155 | 0 / 165 |
| serious Total, serious adverse events | 1 / 409 | 10 / 155 | 15 / 165 |
Outcome results
Primary
Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180
Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all participants with successful IOL implantation in the primary eye.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multifocal IOL | Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 | 0.322 logMAR | Standard Error 0.014 |
| Monofocal IOL | Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 | 0.512 logMAR | Standard Error 0.013 |
Primary
Mesopic Contrast Sensitivity With Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time frame: Day 120-180 from second eye implantation
Population: The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 1.5 cpd (n=127,129) | 1.536 logMAR | Standard Deviation 0.237 |
| Multifocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 3 cpd (n=128,130) | 1.542 logMAR | Standard Deviation 0.292 |
| Multifocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 6 cpd (n=114,126) | 1.543 logMAR | Standard Deviation 0.329 |
| Multifocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 12 cpd (n=90,105) | 1.043 logMAR | Standard Deviation 0.385 |
| Monofocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 12 cpd (n=90,105) | 1.153 logMAR | Standard Deviation 0.375 |
| Monofocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 1.5 cpd (n=127,129) | 1.596 logMAR | Standard Deviation 0.238 |
| Monofocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 6 cpd (n=114,126) | 1.617 logMAR | Standard Deviation 0.277 |
| Monofocal IOL | Mesopic Contrast Sensitivity With Glare at Day 120-180 | 3 cpd (n=128,130) | 1.600 logMAR | Standard Deviation 0.296 |
Primary
Mesopic Contrast Sensitivity Without Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time frame: Day 120-180 from second eye implantation
Population: The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 1.5 cpd (n=128,131) | 1.594 logMAR | Standard Deviation 0.224 |
| Multifocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 3 cpd (n=131,132) | 1.563 logMAR | Standard Deviation 0.267 |
| Multifocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 6 cpd (n=122,130) | 1.581 logMAR | Standard Deviation 0.296 |
| Multifocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 12 cpd (n=102,112) | 1.077 logMAR | Standard Deviation 0.363 |
| Monofocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 12 cpd (n=102,112) | 1.208 logMAR | Standard Deviation 0.345 |
| Monofocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 1.5 cpd (n=128,131) | 1.622 logMAR | Standard Deviation 0.204 |
| Monofocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 6 cpd (n=122,130) | 1.673 logMAR | Standard Deviation 0.275 |
| Monofocal IOL | Mesopic Contrast Sensitivity Without Glare at Day 120-180 | 3 cpd (n=131,132) | 1.618 logMAR | Standard Deviation 0.226 |
Primary
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180
Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.
Time frame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation
Population: This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Iritis (persistent | 2 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Cystoid macular oedema (cumulative) | 4 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Endophthalmitis (cumulative) | 0 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Hypopyon (cumulative) | 0 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Lens dislocated from posterior (cumulative) | 0 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Pupillary block (cumulative) | 0 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Retinal detachment (cumulative) | 0 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Secondary surgical intervention (cumulative) | 0 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Corneal stroma oedema (persistent) | 0 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Cystoid macular oedema (persistent | 2 adverse events |
| Multifocal IOL | Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Raised IOP requiring treatment (persistent) | 0 adverse events |
Primary
Photopic Contrast Sensitivity With Glare at Day 120-180
Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time frame: Day 120-180 from second eye implantation
Population: The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 3 cpd (n=130,131) | 1.608 logMAR | Standard Deviation 0.307 |
| Multifocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 6 cpd (n=117,125) | 1.684 logMAR | Standard Deviation 0.316 |
| Multifocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 12 cpd (n=117,127) | 1.334 logMAR | Standard Deviation 0.321 |
| Multifocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 18 cpd (n=119,128) | 0.914 logMAR | Standard Deviation 0.333 |
| Monofocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 18 cpd (n=119,128) | 1.043 logMAR | Standard Deviation 0.361 |
| Monofocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 3 cpd (n=130,131) | 1.692 logMAR | Standard Deviation 0.274 |
| Monofocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 12 cpd (n=117,127) | 1.475 logMAR | Standard Deviation 0.336 |
| Monofocal IOL | Photopic Contrast Sensitivity With Glare at Day 120-180 | 6 cpd (n=117,125) | 1.844 logMAR | Standard Deviation 0.309 |
Primary
Photopic Contrast Sensitivity Without Glare at Day 120-180
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.
Time frame: Day 120-180 from second eye implantation
Population: The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 3 cpd (n=131,133) | 1.676 logMAR | Standard Deviation 0.259 |
| Multifocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 6 cpd (n=130,133) | 1.816 logMAR | Standard Deviation 0.256 |
| Multifocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 12 cpd (n=129,132) | 1.460 logMAR | Standard Deviation 0.312 |
| Multifocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 18 cpd (n=130,131) | 0.970 logMAR | Standard Deviation 0.348 |
| Monofocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 18 cpd (n=130,131) | 1.109 logMAR | Standard Deviation 0.325 |
| Monofocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 3 cpd (n=131,133) | 1.743 logMAR | Standard Deviation 0.203 |
| Monofocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 12 cpd (n=129,132) | 1.555 logMAR | Standard Deviation 0.312 |
| Monofocal IOL | Photopic Contrast Sensitivity Without Glare at Day 120-180 | 6 cpd (n=130,133) | 1.938 logMAR | Standard Deviation 0.251 |
Secondary
Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180
VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all participants with successful IOL implantation in the primary eye.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multifocal IOL | Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 | 0.025 logMAR | Standard Error 0.009 |
| Monofocal IOL | Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 | 0.003 logMAR | Standard Error 0.009 |
Secondary
Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180
VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all participants with successful IOL implantation in the primary eye.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multifocal IOL | Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 | 0.426 logMAR | Standard Error 0.014 |
| Monofocal IOL | Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 | 0.632 logMAR | Standard Error 0.013 |
Secondary
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses for seeing objects up close?
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Multifocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | None of the time | 25 participants |
| Multifocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Some of the time | 70 participants |
| Multifocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Most of the time | 34 participants |
| Multifocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | All of the time | 24 participants |
| Monofocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | All of the time | 48 participants |
| Monofocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | None of the time | 19 participants |
| Monofocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Most of the time | 40 participants |
| Monofocal IOL | Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Some of the time | 53 participants |
Secondary
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180
Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses overall?
Time frame: Day 120-180 from second eye implantation
Population: This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Multifocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | None of the time | 35 participants |
| Multifocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Some of the time | 104 participants |
| Multifocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Most of the time | 12 participants |
| Multifocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | All of the time | 2 participants |
| Monofocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | All of the time | 5 participants |
| Monofocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | None of the time | 33 participants |
| Monofocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Most of the time | 13 participants |
| Monofocal IOL | Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Some of the time | 109 participants |