Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Spectacle independence utilizing the IOLSAT. |
Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. |
3 months post operatively |
|
Other |
Halo will be reported. |
Halo will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. |
3 months post operatively |
|
Other |
Glare will be reported. |
Glare will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. |
3 months post operatively |
|
Other |
Binocular DCNVA at 33cm. |
Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Primary |
Binocular DCNVA (distance corrected near visual acuity) of Trifocal (Alcon PanOptix) |
Binocular DCNVA of Trifocal (Alcon PanOptix). Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Primary |
Binocular DCNVA of EDOF (extended depth of focus)/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm |
Binocular DCNVA of EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Secondary |
Binocular BCDVA measured at 4m. |
Binocular BCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Secondary |
Binocular DCIVA measured at 60cm. |
Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Secondary |
Binocular UCDVA measured at 4m. |
Binocular UCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Secondary |
Binocular UCIVA measured at 60cm. |
Binocular UCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Secondary |
Binocular UCNVA measured at 40cm. |
Binocular UCNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Secondary |
Binocular target corrected defocus curve |
Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|
Secondary |
Patient self-reported visual disturbances. |
Patient self-reported visual disturbances will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. |
3 months post operatively |
|
Secondary |
Patient reported satisfaction by IOLSAT questionnaire. |
Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. |
3 months post operatively |
|
Secondary |
Patient reported satisfaction by QUVID questionnaire. |
Patient reported satisfaction by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. |
3 months post operatively |
|
Secondary |
Post operative refraction. |
Post operative refraction. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
3 months post operatively |
|