Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.