Cataract
Conditions
Keywords
Intraocular lens, IOL
Brief summary
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.
Detailed description
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.
Interventions
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
DEVICEAcrySof Monofocal IOL
AcrySof Monofocal IOL Model SN60AT for single vision
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision * Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures * Clear intraocular media other than cataract in both eyes. * Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.
Exclusion criteria
* Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema * Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions) * Glaucoma (uncontrolled or controlled with medication) * Degenerative eye disorders (e.g. macular degeneration or other retinal disorders) * Pregnant or lactating * Expected to require a second surgical intervention or retinal laser treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | Month 6 (Day 120-180), post second eye implantation | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye | Up to Month 6 (Day 120-180), post second eye implantation | The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure. |
| Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | Month 6 (Day 120-180), post second eye implantation | Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Mean Photopic With Glare Binocular Distance Contrast Sensitivity | Month 6 (Day 120-180), post second eye implantation | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | Month 6 (Day 120-180), post second eye implantation | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) | Month 6 (Day 120-180), post second eye implantation | Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. |
| Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) | Month 6 (Day 120-180), post second eye implantation | VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire | Month 6 (Day 120-180), 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 proportion of subjects who respond Never is reported as a percentage calculated as (# of subjects responding Never) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. |
| Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Month 6 (Day 120-180), post second eye implantation | QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding Severe was calculated as (# of subjects responding Severe) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure. |
| Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Month 6 (Day 120-180), post second eye implantation | Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding Bothered very much) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure. |
| Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) | Month 6 (Day 120-180), post second eye implantation | VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 12 investigative sites located in the United States.
Pre-assignment details
Of the 250 enrolled, 7 subjects were exited as screen failures prior to attempted implantation. This reporting group includes all subjects with at least one eye implanted (243).
Participants by arm
| Arm | Count |
|---|---|
| TFNT00 AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | 129 |
| SN60AT AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | 114 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Total | TFNT00 | SN60AT |
|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 7.09 | 65.8 years STANDARD_DEVIATION 7.31 | 69.0 years STANDARD_DEVIATION 6.46 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 7 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 8 Participants | 11 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 209 Participants | 113 Participants | 96 Participants |
| Sex: Female, Male Female | 164 Participants | 85 Participants | 79 Participants |
| Sex: Female, Male Male | 79 Participants | 44 Participants | 35 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 243 | 0 / 129 | 0 / 127 | 0 / 129 | 0 / 114 | 0 / 111 | 0 / 114 |
| other Total, other adverse events | 1 / 243 | 24 / 129 | 24 / 127 | 0 / 129 | 10 / 114 | 7 / 111 | 0 / 114 |
| serious Total, serious adverse events | 0 / 243 | 2 / 129 | 2 / 127 | 4 / 129 | 2 / 114 | 1 / 111 | 3 / 114 |
Outcome results
Primary
Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye
The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.
Time frame: Up to Month 6 (Day 120-180), post second eye implantation
Population: This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| TFNT00 | Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye | 1 Eyes |
| SN60AT | Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye | 0 Eyes |
Primary
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: Safety Analysis Set with contrast sensitivity test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.709 log units | Standard Deviation 0.2307 |
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.129 log units | Standard Deviation 0.4146 |
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.691 log units | Standard Deviation 0.3238 |
| TFNT00 | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 1.5 cpd | 1.658 log units | Standard Deviation 0.2296 |
| SN60AT | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.786 log units | Standard Deviation 0.2775 |
| SN60AT | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.233 log units | Standard Deviation 0.4599 |
| SN60AT | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.692 log units | Standard Deviation 0.2089 |
| SN60AT | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | 1.5 cpd | 1.678 log units | Standard Deviation 0.2091 |
Primary
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: Safety Analysis Set with contrast sensitivity test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 1.5 cpd | 1.673 log units | Standard Deviation 0.2601 |
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.715 log units | Standard Deviation 0.2875 |
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.211 log units | Standard Deviation 0.4047 |
| TFNT00 | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.717 log units | Standard Deviation 0.2397 |
| SN60AT | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.290 log units | Standard Deviation 0.4384 |
| SN60AT | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 1.5 cpd | 1.679 log units | Standard Deviation 0.219 |
| SN60AT | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.689 log units | Standard Deviation 0.2177 |
| SN60AT | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.777 log units | Standard Deviation 0.2871 |
Primary
Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: All-Implanted Analysis Set with data available at the visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TFNT00 | Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) | -0.014 logMAR | Standard Error 0.0083 |
| SN60AT | Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) | -0.039 logMAR | Standard Error 0.0087 |
Primary
Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: All-Implanted Analysis Set with data at visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TFNT00 | Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) | 0.105 logMAR | Standard Error 0.0119 |
| SN60AT | Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) | 0.529 logMAR | Standard Error 0.0127 |
p-value: <0.001Mixed Models Analysis
Primary
Mean Photopic With Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: Safety Analysis Set with contrast sensitivity test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.759 log units | Standard Deviation 0.189 |
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.897 log units | Standard Deviation 0.2322 |
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.566 log units | Standard Deviation 0.2728 |
| TFNT00 | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 18 cpd | 1.037 log units | Standard Deviation 0.2762 |
| SN60AT | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 18 cpd | 1.121 log units | Standard Deviation 0.2537 |
| SN60AT | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.753 log units | Standard Deviation 0.1928 |
| SN60AT | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.593 log units | Standard Deviation 0.2659 |
| SN60AT | Mean Photopic With Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.971 log units | Standard Deviation 0.1952 |
Primary
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: Safety Analysis Set with contrast sensitivity test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.752 log units | Standard Deviation 0.208 |
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.923 log units | Standard Deviation 0.2349 |
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.527 log units | Standard Deviation 0.2793 |
| TFNT00 | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 18 cpd | 0.993 log units | Standard Deviation 0.2874 |
| SN60AT | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 18 cpd | 1.090 log units | Standard Deviation 0.2661 |
| SN60AT | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 3 cpd | 1.733 log units | Standard Deviation 0.1989 |
| SN60AT | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 12 cpd | 1.558 log units | Standard Deviation 0.2566 |
| SN60AT | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | 6 cpd | 1.940 log units | Standard Deviation 0.2328 |
Secondary
Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: All-Implanted Analysis Set with data at visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TFNT00 | Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) | 0.070 logMAR | Standard Error 0.0108 |
| SN60AT | Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) | 0.327 logMAR | Standard Error 0.0114 |
p-value: <0.00195% CI: [-0.287, -0.227]Mixed Models Analysis
Secondary
Proportion of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire
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 proportion of subjects who respond Never is reported as a percentage calculated as (# of subjects responding Never) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: This analysis population includes all subjects with bilateral implantation and concordant, non-missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TFNT00 | Proportion of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire | 80.5 percentage of subjects |
| SN60AT | Proportion of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire | 8.2 percentage of subjects |
95% CI: [61.87, 80.46]
Secondary
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID
Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding Bothered very much) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: This analysis population includes all subjects with bilateral implantation and non-missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TFNT00 | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Dark area | 0 Participants |
| TFNT00 | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Starbursts | 6 Participants |
| TFNT00 | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Halos | 3 Participants |
| TFNT00 | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Glare | 2 Participants |
| TFNT00 | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Hazy vision | 0 Participants |
| TFNT00 | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Blurred vision | 0 Participants |
| TFNT00 | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Double vision | 0 Participants |
| SN60AT | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Glare | 1 Participants |
| SN60AT | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Dark area | 0 Participants |
| SN60AT | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Hazy vision | 1 Participants |
| SN60AT | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Starbursts | 1 Participants |
| SN60AT | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Double vision | 0 Participants |
| SN60AT | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Halos | 1 Participants |
| SN60AT | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Blurred vision | 2 Participants |
Secondary
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)
QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding Severe was calculated as (# of subjects responding Severe) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 6 (Day 120-180), post second eye implantation
Population: This analysis population includes all subjects with bilateral implantation and non-missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TFNT00 | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Halos | 16 Participants |
| TFNT00 | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Hazy vision | 0 Participants |
| TFNT00 | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Blurred vision | 0 Participants |
| TFNT00 | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Starbursts | 20 Participants |
| TFNT00 | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Double vision | 0 Participants |
| TFNT00 | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Glare | 4 Participants |
| TFNT00 | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Dark area | 0 Participants |
| SN60AT | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Glare | 2 Participants |
| SN60AT | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Hazy vision | 0 Participants |
| SN60AT | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Dark area | 0 Participants |
| SN60AT | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Halos | 1 Participants |
| SN60AT | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Starbursts | 2 Participants |
| SN60AT | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Blurred vision | 0 Participants |
| SN60AT | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | Double vision | 0 Participants |