Trial Outcomes & Findings for Post-Approval Study of the TECNIS SYMFONY® Toric Lenses (NCT NCT03791619)
NCT ID: NCT03791619
Last Updated: 2023-08-29
Results Overview
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
475 participants
Primary outcome timeframe
6-month
Results posted on
2023-08-29
Participant Flow
It includes all subjects with ZXT300/375/150 toric IOL in the primary eye.
Participant milestones
| Measure |
Higher Cylinder Group
All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.
|
Lower Cylinder Group
All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
|
|---|---|---|
|
Overall Study
STARTED
|
260
|
215
|
|
Overall Study
COMPLETED
|
256
|
209
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Baseline characteristics by cohort
| Measure |
Higher Cylinder Group
n=260 Participants
All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.
|
Lower Cylinder Group
n=215 Participants
All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
|
Total
n=475 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
68.2 Years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
68.7 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-monthPopulation: Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Outcome measures
| Measure |
Higher Cylinder Group
n=256 Participants
All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.
|
Lower Cylinder Group
n=209 Participants
All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
|
|---|---|---|
|
Rate of Bothersome Visual Symptoms
|
19 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: 6-monthPopulation: Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
Outcome measures
| Measure |
Higher Cylinder Group
n=256 Participants
All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.
|
Lower Cylinder Group
n=209 Participants
All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
|
|---|---|---|
|
Rate of Difficulty With an Activity Due to the Visual Symptoms
|
28 Participants
|
26 Participants
|
Adverse Events
Higher Cylinder Group
Serious events: 34 serious events
Other events: 12 other events
Deaths: 0 deaths
Lower Cylinder Group
Serious events: 33 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Higher Cylinder Group
n=260 participants at risk
All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.
|
Lower Cylinder Group
n=215 participants at risk
All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
|
|---|---|---|
|
Eye disorders
Cystoid Macular Edema
|
2.7%
7/260 • Number of events 7 • 6 months
|
3.7%
8/215 • Number of events 10 • 6 months
|
|
Eye disorders
Vitreous Hemorrhage
|
0.00%
0/260 • 6 months
|
0.47%
1/215 • Number of events 1 • 6 months
|
|
Eye disorders
Undesirable Optical Phenomena
|
0.38%
1/260 • Number of events 1 • 6 months
|
0.93%
2/215 • Number of events 2 • 6 months
|
|
Eye disorders
Elevated IOP requiring treatment
|
2.7%
7/260 • Number of events 8 • 6 months
|
3.3%
7/215 • Number of events 7 • 6 months
|
|
Eye disorders
Non-Ischemic Optic Neuropathy
|
0.00%
0/260 • 6 months
|
0.47%
1/215 • Number of events 1 • 6 months
|
|
Eye disorders
Lens Axis Misalignment requiring SSI
|
2.3%
6/260 • Number of events 6 • 6 months
|
0.00%
0/215 • 6 months
|
|
Eye disorders
Retinal Detachment/Tear
|
0.38%
1/260 • Number of events 1 • 6 months
|
0.00%
0/215 • 6 months
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.00%
0/260 • 6 months
|
0.47%
1/215 • Number of events 1 • 6 months
|
|
Eye disorders
Visual Symptoms requiring SSI
|
0.77%
2/260 • Number of events 3 • 6 months
|
0.00%
0/215 • 6 months
|
|
Eye disorders
Tilt & decentration requiring SSI
|
0.00%
0/260 • 6 months
|
0.47%
1/215 • Number of events 1 • 6 months
|
|
Eye disorders
IOP Elevated Without Need for Treatment
|
1.2%
3/260 • Number of events 3 • 6 months
|
0.93%
2/215 • Number of events 2 • 6 months
|
|
Eye disorders
Corneal Edema
|
0.38%
1/260 • Number of events 1 • 6 months
|
0.00%
0/215 • 6 months
|
|
Eye disorders
Iritis
|
0.38%
1/260 • Number of events 1 • 6 months
|
0.00%
0/215 • 6 months
|
|
Eye disorders
IOP Greater than 10mmHg from Screening and More than 25mmHg
|
0.00%
0/260 • 6 months
|
0.93%
2/215 • Number of events 2 • 6 months
|
|
General disorders
Hospitalization
|
2.3%
6/260 • Number of events 8 • 6 months
|
2.3%
5/215 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Breathing
|
0.00%
0/260 • 6 months
|
0.47%
1/215 • Number of events 1 • 6 months
|
|
General disorders
Cancer
|
0.38%
1/260 • Number of events 1 • 6 months
|
0.47%
1/215 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Wrist Fracture Surgery
|
0.00%
0/260 • 6 months
|
0.47%
1/215 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia/COVID-19
|
0.38%
1/260 • Number of events 1 • 6 months
|
0.00%
0/215 • 6 months
|
Other adverse events
| Measure |
Higher Cylinder Group
n=260 participants at risk
All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye.
|
Lower Cylinder Group
n=215 participants at risk
All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
|
|---|---|---|
|
Eye disorders
Undesirable Optical Phenomena
|
4.6%
12/260 • Number of events 12 • 6 months
|
0.93%
2/215 • Number of events 2 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.
- Publication restrictions are in place
Restriction type: OTHER