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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P980040 S058/ PAS001 |
| Date Original Protocol Accepted |
07/31/2015
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| Date Current Protocol Accepted |
03/03/2017
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| Study Name |
ECR IOL PAS
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| Device Name |
TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU
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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 |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this post-approval study is to evaluate the rates of severe visual distortions for the TECNIS Toric IOLs
with Extended Cylinder Range of approximately 3.00 D to 4.75 D of cylinder correction at the corneal plane (Models
ZCT450, ZCT525 and ZCT600) in clinical practice and to ensure the continued safety of the approved devices.
Study Design: Prospective, multicenter, bilateral, non-randomized, open-label clinical new enrollment study.
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| Study Population |
Bilateral cataracts with corneal astigmatism of approximately 2.00 D to 4.75 D (with 3.00 D to 4.75 D in at least one eye) based on the combination of preoperative keratometirc cylinder and the expected effect of surgicallyinduced astigmatism (SIA).There is no control group.
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| Sample Size |
Up to 120 subjects will be enrolled to achieve bilateral implantation in approximately 80 subjects; a minimum of 15 subjects will be implanted with a TECNIS Toric ZCT600 in at least one eye, and the remaining subjects will be implanted with either a TECNIS Toric ZCT450, ZCT525 or ZCT600 in at least one eye. With 80 subjects and a severe visual distortion rate of 0.025, this study has 86% probability of achieving a half-width of 0.05 for a 95% confidence interval for the rate of severe visual distortions.
Subjects will be enrolled at up to 20 sites in the United States. Each site should implant a minimum of 6 subjects, and no site may enroll more than 20% of the enrollment total.
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| Key Study Endpoints |
Study Endpoints
Primary Endpoint
The primary endpoint is the rate of severe visual distortions based on data collected from a self-administered Patient
Reported Visual Distortion Questionnaire (PRVDQ).
The rate of severe visual distortions is 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
flat surfaces appearing curved
objects appearing further away or closer than they actually are objects appearing to have a different size or shape
physical discomfort related to vision
Distortions will be assessed using the overall circumstance reply at the 6-month visit. The frequency and proportion of subjects reporting one or more of these items as severe will be used to determine the rate of severe visual distortions.
Secondary Endpoints
Ratings of individual items included in the visual distortion questionnaire (PRVDQ)
Mean percent reduction in absolute cylinder
Mean refractive cylinder, mean refractive cylinder compared to intended, mean spherical equivalent and mean spherical equivalent compared to intended
Percent of eyes with absolute cylinder within 0.50 D and within 1.00 D of intended
Percent of eyes with spherical equivalent within 0.50 D and within 1.00 D of intended
Uncorrected distance visual acuity (monocular and binocular)
Best corrected distance visual acuity (monocular and binocular)
Rates of medical and/or lens findings
Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment
Mean difference between IOL axis marker location and postoperative steep keratometry meridian
Rates of other adverse events
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| Follow-up Visits and Length of Follow-up |
6 months total follow up
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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 |
20
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| Patient Follow-up Rate |
Overall follow-up rate among those enrolled: 86% (101/118)
The follow-up rate among those implanted was 100% (101/101).
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| Final Safety Findings |
Of the 100 subjects completing the PRVDQ questionnaire at 6 months, none reported severe visual distortions under overall circumstances for any of the five items of interest.
A small number of subjects reported severe symptoms on questions in the PRVDQ questionnaire, pertaining to other visual symptoms.
Lens findings of misalignment were the most common finding reported by the investigator, for a total of 18 eyes.
A total of 15 subjects experienced 17 ocular serious/device-related adverse events (SAE/ADEs) in 17 eyes as determined by the investigators. Sixteen 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 11.9%) of IOL misalignment that required secondary surgical intervention to reposition the lens.
One had an IOL exchange due to residual astigmatism and myopia from the initial IOL. One incidence of iridocyclitis was reported but was not considered serious nor device-related and resolved without sequelae. One report of cystoid macular edema was reported but has also resolved without sequelae.
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| Final Effect Findings |
The refractive endpoint outcomes and visual acuity results do not raise any concerns because the refractive endpoint outcomes included satisfactory effectiveness results. However, I will defer Dr. Hilmantel, clinical reviewer, for his clinical assessment.
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| Study Strengths & Weaknesses |
Strength: 100% follow-up rate, there is a comparator group.
Weaknesses: Small sample size (100), no randomization, lack of representativeness (94% 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 the following:
Demographic distribution results.
o Protocol deviations reported during the study: 118 enrolled patients 76 deviations
(64.4%).
o Numbers and rates of secondary surgical interventions to correct misalignments for the
lenses with the high corneal astigmatism under investigation. Rates should be reported
both “per eye” and “per subjects”.
o A full description of the distributions of residual refractive cylinder and “residual
cylinder – target cylinder.” These should include the following percentiles: 0th, 5th,
10th, 25th, 50th, 75th, 90th, 95th, and 100th percentiles.
o Secondary surgical interventions occur at a substantially higher rate for subjects
receiving implants for TECNIS® Toric IOL models with higher cylinder powers than for
those receiving lower cylinder models; and
o Patients requiring implants for TECNIS® Toric IOL models with higher cylinder powers
are likely to have greater residual astigmatism and poorer uncorrected visual acuities
than those requiring lower cylinder models. Those requiring high cylinder models are
more likely to need spectacle correction at distance for some tasks.
o A full description of the distribution of monocular uncorrected visual acuities, including
the proportions of eyes with logMAR acuity worse than 0.3, 0.2, and 0.1. They should
also provide the following percentiles for monocular uncorrected acuities: 0th, 5th,
10th, 25th, 50th, 75th, 90th, 95th, and 100th percentiles.
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