Trial Outcomes & Findings for Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy (NCT NCT06041139)
NCT ID: NCT06041139
Last Updated: 2025-05-23
Results Overview
Binocular DCNVA 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.
Recruitment status
COMPLETED
Target enrollment
230 participants
Primary outcome timeframe
3 months post operatively
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Alcon PanOptix
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
77
|
|
Overall Study
COMPLETED
|
153
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 8.3 • n=153 Participants
|
65.9 years
STANDARD_DEVIATION 10.2 • n=77 Participants
|
65.7 years
STANDARD_DEVIATION 9.0 • n=230 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=153 Participants
|
51 Participants
n=77 Participants
|
138 Participants
n=230 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=153 Participants
|
26 Participants
n=77 Participants
|
92 Participants
n=230 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 3 months post operativelyBinocular DCNVA 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm
|
0.03 logMAR
Standard Deviation 0.08
|
0.01 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 3 months post operativelyBinocular CDVA 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.
|
-0.06 logMAR
Standard Deviation 0.06
|
-0.07 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 3 months post operativelyBinocular 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.
|
0.00 logMAR
Standard Deviation 0.08
|
0.00 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 3 months post operativelyBinocular UDVA 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.
|
-0.01 logMAR
Standard Deviation 0.08
|
0.00 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 3 months post operativelyBinocular UIVA 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.
|
0.00 logMAR
Standard Deviation 0.08
|
0.00 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 3 months post operativelyBinocular UNVA 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.
|
0.03 logMAR
Standard Deviation 0.08
|
0.03 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 3 months post operativelyBinocular 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Binocular Target Corrected Defocus Curve
-3.00 D
|
0.12 logMAR
Standard Deviation 0.09
|
0.09 logMAR
Standard Deviation 0.09
|
|
Binocular Target Corrected Defocus Curve
-2.50 D
|
0.03 logMAR
Standard Deviation 0.08
|
0.03 logMAR
Standard Deviation 0.09
|
|
Binocular Target Corrected Defocus Curve
-2.00 D
|
-0.01 logMAR
Standard Deviation 0.08
|
0.01 logMAR
Standard Deviation 0.09
|
|
Binocular Target Corrected Defocus Curve
-1.00 D
|
0.10 logMAR
Standard Deviation 0.09
|
0.06 logMAR
Standard Deviation 0.09
|
|
Binocular Target Corrected Defocus Curve
-0.50 D
|
0.06 logMAR
Standard Deviation 0.07
|
0.03 logMAR
Standard Deviation 0.07
|
|
Binocular Target Corrected Defocus Curve
-0.25 D
|
-0.02 logMAR
Standard Deviation 0.07
|
-0.04 logMAR
Standard Deviation 0.06
|
|
Binocular Target Corrected Defocus Curve
0.00 D
|
-0.07 logMAR
Standard Deviation 0.07
|
-0.06 logMAR
Standard Deviation 0.06
|
|
Binocular Target Corrected Defocus Curve
0.25 D
|
-0.03 logMAR
Standard Deviation 0.07
|
-0.01 logMAR
Standard Deviation 0.08
|
|
Binocular Target Corrected Defocus Curve
0.50 D
|
0.04 logMAR
Standard Deviation 0.07
|
0.04 logMAR
Standard Deviation 0.09
|
|
Binocular Target Corrected Defocus Curve
1.00 D
|
0.22 logMAR
Standard Deviation 0.10
|
0.21 logMAR
Standard Deviation 0.11
|
|
Binocular Target Corrected Defocus Curve
-1.50 D
|
0.02 logMAR
Standard Deviation 0.09
|
0.02 logMAR
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 3 months post operativelyPatient 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. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Patient Reported Satisfaction by IOLSAT Questionnaire.
|
89 percentage of participants
|
94 percentage of participants
|
SECONDARY outcome
Timeframe: 3 months post operativelyPatient reported disphotopsias 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. The percentage of subjects that answered "Never" for frequency are provided.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Patient Reported Dysphotopsias Questionnaire (QUVID).
Starbursts
|
65 percentage of participants
|
49 percentage of participants
|
|
Patient Reported Dysphotopsias Questionnaire (QUVID).
Halos
|
38 percentage of participants
|
38 percentage of participants
|
|
Patient Reported Dysphotopsias Questionnaire (QUVID).
Blurred Vision
|
87 percentage of participants
|
75 percentage of participants
|
|
Patient Reported Dysphotopsias Questionnaire (QUVID).
Double Vision
|
97 percentage of participants
|
100 percentage of participants
|
|
Patient Reported Dysphotopsias Questionnaire (QUVID).
Dark Area
|
98 percentage of participants
|
96 percentage of participants
|
|
Patient Reported Dysphotopsias Questionnaire (QUVID).
Glare
|
48 percentage of participants
|
55 percentage of participants
|
|
Patient Reported Dysphotopsias Questionnaire (QUVID).
Haze
|
84 percentage of participants
|
86 percentage of participants
|
SECONDARY outcome
Timeframe: 3 months post operativelyPost operative refraction. 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.
Outcome measures
| Measure |
Alcon PanOptix
n=206 eyes
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=144 eyes
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).
|
0.24 D
Standard Deviation 0.26
|
0.23 D
Standard Deviation 0.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post operativelySpectacle 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. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
|
|---|---|---|
|
Spectacle Independence Utilizing the IOLSAT.
Overall
|
92 percentage of participants
|
97 percentage of participants
|
|
Spectacle Independence Utilizing the IOLSAT.
Distance
|
99 percentage of participants
|
100 percentage of participants
|
|
Spectacle Independence Utilizing the IOLSAT.
Intermediate
|
99 percentage of participants
|
100 percentage of participants
|
|
Spectacle Independence Utilizing the IOLSAT.
Near
|
93 percentage of participants
|
96 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post operativelyBinocular 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.
Outcome measures
| Measure |
Alcon PanOptix
n=153 Participants
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
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Johnson & Johnson Synergy
n=77 Participants
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
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Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.
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0.09 logMAR
Standard Deviation 0.09
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0.04 logMAR
Standard Deviation 0.08
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Adverse Events
Alcon PanOptix
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Johnson & Johnson Synergy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place