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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040020 S049/ PAS001 |
| Date Original Protocol Accepted |
10/11/2018
|
| Date Current Protocol Accepted |
08/28/2020
|
| Study Name |
AcrySof IQ ReSTOR +3.0 Toric PAS
|
| Device Name |
ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS
|
| Clinical Trial Number(s) |
NCT01200511
NCT01257217
NCT01290068
NCT01323777
NCT01424189
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Phase A: This is a prospective, multicenter, post-approval active surveillance study to report the rate of post-surgical intraocular inflammation
(based upon a specified case definition) reported within a 180-day post-surgical period following implantation of an ACRYSOF IQ
RESTOR Toric IOL in the US.
Phase B: This is a retrospective epidemiological study to estimate the historical background rate of post-surgical intraocular inflammation following
implantation of an intraocular lens (IOL) in the United States. All cataract surgeries reported in 2011 through 2013 in the Medicare Limited Data Set
(LDS) files will be reviewed to look at the frequency of post-surgical intraocular inflammation within 180 days of cataract surgery.
|
| Study Population |
Cohort 1: Adult subjects, 22 years of age or older, implanted from November 2018 through July 2020 with an ACRYSOF® IQ RESTOR® Multifocal Toric IOL (+3.0 D or +2.5 D). The study enrollment is complete for Cohort 1.
Cohort 2: Adult subjects, 22 years of age or older, implanted after July 2020 with an ACRYSOF® IQ RESTOR® +3.0 D Multifocal Toric IOL or ACRYSOF® IQ RESTOR® +2.5 D Multifocal IOL.
Phase B:
Data from the Part B (Physician/Supplier) files from all beneficiaries with one or more claims for cataract surgery in 2011 to 2013 were considered.
The Part B file encompasses service by the ophthalmologist in both inpatient and outpatient settings.
|
| Sample Size |
Cohort 1: 478 subjects were enrolled, 706 eyes were implanted, and 703 eyes completed the postoperative follow-up evaluation up to 180 days.
Cohort 2: 3600 eyes will enroll to implant 3300 from 30 sites across the U.S. to ensure 3,000 eyes evaluable for up to postoperative 180 days.
|
| Key Study Endpoints |
There are no performance endpoints in this study.
Safety Endpoints:
The primary safety endpoint is the rate (per 1,000 IOL implants) of post-surgical intraocular inflammation (based upon the specified case definition) reported within a 180-day post-surgical period following attempted implantation of ACRYSOF® IQ RESTOR® Toric +3.0 D Multifocal IOL or ACRYSOF® IQ ReSTOR® +2.5 D Multifocal IOL (Cohort 2).
The secondary safety endpoints are the rates (per 1,000) of Toxic Anterior Segment Syndrome (TASS), acute postoperative endophthalmitis, chronic postoperative endophthalmitis, and uncategorized cases of post-surgical intraocular inflammation (based upon the specified case definition), respectively, reported within a 180-day post-surgical period following implantation of ACRYSOF® IQ RESTOR® Toric IOLs or ACRYSOF® IQ ReSTOR® IOL (Cohort 2).
|
| Follow-up Visits and Length of Follow-up |
Within postoperative 180 days.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1972
|
| Actual Number of Sites Enrolled |
34
|
| Patient Follow-up Rate |
Subjects, n (%)
1747 (97.49) successfully implanted
45 (2.51) discontinued subjects include 30 (1.67) lost to follow up with the other 15 subjects discontinued due to death, adverse event(s), or withdrawal by subject.
|
| Final Safety Findings |
According to Section 4.4.1 of report, overall rate of postsurgical inflammation (any type) was 5.1 per 100 attempted implants (two-sided 95% CI 2.95, 8.10). It was similar for first and second eyes; none of the cases were assessed to be related to study device. Subgroup analysis by age showed a similar rate of postsurgical inflammation in subjects < 65 years (5.0 events per 1000) and subjects greater than or equal to 65 years (5.1 events per 1000). For comparison purposes, Cohort 1's rate was much higher 8.5 per 1000 implants (2-sided 95% CI 3.13, 18.41), and the rate reported in PAS Phase B Medicare study was also much higher at 10.31 per 1000 implants (95% CI 9.89, 10.74). Most eyes (14) had uncategorized inflammation, 2 eyes had TASS, and 1 eye had acute postoperative endophthalmitis.
Ocular adverse events (AE) occurred in about 17% of eyes; AEs are consistent with known risks in cataract surgery. Ocular serious AE (SAE) rate was relatively rare at 1.22%. Individual SAEs n (%):
Vitrectomy, 12 (0.36)
Cataract Surgery Complication, 10 (0.3)
Device dislocation, 6 (0.18)
IOL repositioning, 11 (0.33)
Lens extraction, 9 (0.27)
Glare, 4 (0.12)
Retinal detachment, 5 (0.15)
cystoid macular edema, 4 (0.12)
All other SAE rates were below 0.1%
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| Final Effect Findings |
Study is focused only on device safety, so there are no effectiveness endpoints.
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| Study Strengths & Weaknesses |
5 eye implanted with non study IOL; they were excluded from all analyses. There were no other protocol deviations since previous report
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| Recommendations for Labeling Changes |
No labeling changes because Applicant has stopped manufacturing the subject device
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