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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P980040 S039/ PAS001 |
| Date Original Protocol Accepted |
04/15/2013
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| Date Current Protocol Accepted |
04/23/2018
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| Study Name |
New Enrollment of Post Approval Study
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| Device Name |
TECNIS TORIC 1-PEICE INTRAOCULAR LENS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this post-approval study is to evaluate the rates of visual distortions for the TECNIS Toric IOLs with >2.0 D of cylinder correction at the corneal plane (Models ZCT300 and ZCT400) in a larger population in clinical practice compared to a non-toric control IOL.
The design is a prospective, multi-center, bilateral, non- randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA.
Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference.
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| Study Population |
Patients with bilateral cataracts with corneal astigmatism of approximately 2.00 D to 3.62 D based on the combination of preoperative keratometric cylinder and the expected effect of surgically induced astigmatism.
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| Sample Size |
A sample size of a minimum of 396 enrolled subjects to achieve bilateral implantation of approximately 294 subjects: 169 TECNIS Toric ZCT300 and ZCT400 and 125 control subjects will be enrolled.
A two-group large-sample normal approximately test of proportions with a one- sided 0.05 signficance level using only 37 evaluable toric subjects and 27 evaluable control subjects will have a greater than 90% power to detect a rate of severe visual distortions for toric subjects as being 10 percentage points or greater than that for control subjects. This assumes severe visual distortion rates of 1% for both the toric and control subjects. Therefore, the sample size proposed for a minimum of 396 enrolled subjects, assuming a 10% drop out rate for a minimum of 152 toric and 112 control subjects available for evaluation at 6 months, is sufficient to demonstrate a non-inferiority in the rate of severe visual distortions (the primary endpoint of this study) between the two study groups in a larger population in clinical practice, and thereby demonstrate the continued safety of the toric IOLs.
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| Key Study Endpoints |
Primary Endpoint
Rate of severe visual distortions; defined as the percentage of subjects who report a severe visual distortion under overall circumstances at 6 months postoperative for any of
the following 5 visual distortion items of interest:
-lines that slant, tilt, split or separate o flat surfaces appearing curved
-objects appearing further away or closer than they actually are
-objects appearing to have a different size or shape o physical discomfort related to vision.
Other Endpoints
Ratings of individual items included on the visual distortion questionnaire
Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment
Rates of other adverse events
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| Follow-up Visits and Length of Follow-up |
Six months; any subjects that undergo a lens repositioning
procedure due to IOL misalignment or that report a severe visual distortion at six months, will be followed through 1 year postoperatively.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
118 (101 patients implanted)
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| Actual Number of Sites Enrolled |
44
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| Patient Follow-up Rate |
Overall follow-up rate among those enrolled: 104% (429/396)
The follow-up rate among those implanted was 95.8% at 1-month, 93.8% at 6-month, and 91.3% at 1-
year
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| Final Safety Findings |
The rate of severe visual distortion was 0% and 1.4% for the Toric and control groups, respectively;
None in the Toric group, and two subjects in the control group reported severe visual distortion
under overall circumstances for the 5 items of interest in the questionnaire at 6-months.
The percentage of subjects who completed the 6-month questionnaire and reported severe visual
distortions at the 6-month visit was 5.9% (11/187) in the Toric group and 5.0% (7/141) in the control
group. The 11 Toric subjects reported 14 severe visual distortions while the 7 control subjects
reported 22 severe visual distortions.
There were no unexpected medical findings. Lens findings of misalignment were the most common
finding reported by the investigator.
A total of 33 subjects experienced 42 ocular serious/device-related adverse events (SAE/ADEs) in 38
eyes as determined by the investigators. Forty events were categorized as serious by medical
monitor(s) based on the definition of SAE per the protocol. These included 12 reports (a rate of
5.6%, 12/214) of IOL misalignment that required secondary surgical intervention to reposition the
lens all resolved without sequelae.
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| Final Effect Findings |
No effectiveness study endpoints were included in the approved protocol.
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| Study Strengths & Weaknesses |
Strength: More than 80% follow-up rate, there is a comparator group.
Weaknesses: No randomization, lack of representativeness (92% were White).
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| Recommendations for Labeling Changes |
The PAS study design, methods and results must be included in the labeling.
Additionally, it should be included in the following: protocol deviations results and sensitivity analysis
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