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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030016 S035/ PAS001 |
| Date Original Protocol Accepted |
05/04/2022
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| Date Current Protocol Accepted |
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| Study Name |
CP19-01 PAS F/u of PMA Cohort
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| Device Name |
EVO/EVO+VISIAN Implantable Collamer Lens
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| Clinical Trial Number(s) |
NCT04283149
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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 |
Historical 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 continued safety and effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in the original PMA P030016/S035 cohort.
The study design is a continued follow-up of premarket cohorts of the original PMA P030016/S035 study which enrolled and implanted 327 subjects (327 primary eyes and an additional 302 fellow eyes) at 14 clinical sites in the US. Post approval follow-up of the PMA cohort will continue through the Year 3 visit (Postoperative Visit 8, Day 1050 – 1170).
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| Study Population |
The study population includes all subjects enrolled and who completed Postoperative Visit 5 under the original study protocol for Study CP19-01 (approved under IDE G190184).
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| Sample Size |
In order to detect an AE with a true probability of occurrence among eyes of 1% with 95% probability, based on the binomial distribution, a sample of at least 300 eyes is required.
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| Key Study Endpoints |
Co-Primary Endpoints
Co-primary endpoints will be evaluated in all eyes (primary and fellow eyes) using descriptive statistics with comparisons to PMA data for the approved and currently marketed MICL and TMICL devices, where appropriate. The co-primary endpoints have no prespecified performance targets.
Distribution of percent endothelial cell density (ECD) losses and the percent of eyes that have ECD <1500 and ECD <1000 through Postoperative Visit 8 (Day 1050 – 1170).
Incidence of adverse events (AEs) through Postoperative Visit 8 (Day 1050 – 1170).
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| Follow-up Visits and Length of Follow-up |
Subjects will be seen for 3 study visits in this PAS at the following timepoints after the original date of surgery: Year 1 (Days 330-420), Year 2 (Days 690-810) and Year 3 (Days 1050-1170).
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
327 subjects (629 eyes)
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| Actual Number of Sites Enrolled |
14
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| Patient Follow-up Rate |
All 327 subjects (629 eyes) had undergone surgery in the pre-approval phase.
619 eyes (98.6%) available for month 6 analysis (pre-approval end)
615 eyes (97.9%) available for year 1 analysis
585 eyes (93.6%) available for year 2 analysis
579 eyes (92.1%) available for year 3 analysis
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| Final Safety Findings |
The mean (SD) percent endothelial cell density (ECD) loss three year following EVO/EVO+ Visian Implantable Collamer Lens (ICL) insertion was 6.7% (5.4) in all eyes. For comparison, the mean (SD) endothelial cell loss at 3 years reported in the ICL for Myopia (MICL) PMA Clinical Study for the consistent cohort of 154 eyes was 8.9%.
The proportions of eyes with loss of greater than or equal to 10%, greater than or equal to 20% and greater than or equal to 30% ECD in the MICL PMA Clinical Study at 3 years were 33.3%, 9.1% and 1.5%, compared with 20.5%, 2.1% and 0.52% of eyes with loss of greater than or equal to 10%, greater than or equal to 20% and greater than or equal to 30% ECD in this study.
No eyes in this study were reported to have ECD <1500 or <1000 cells/mm2 through Year 3.
No unanticipated adverse events (AEs) or deaths caused by or associated with the use of the device were reported in subjects through Year 3.
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| Final Effect Findings |
Accurate and stable refractive correction was achieved from -3 to almost -16 D spherical equivalent, with 90.7% of eyes within 0.50 D of target and 99.0% of eyes within 1.00 D of target at 3 years was achieved. At least 92% of eyes achieved uncorrected distance visual acuity (UDVA) of 20/25 or better at each time point from Month 6 to Year 3. The data show outstanding preservation of corrected distance visual acuity (CDVA), with 100% of eyes 20/32 or better at 3 years.
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| Study Strengths & Weaknesses |
N/A
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| Recommendations for Labeling Changes |
The Applicant did not request any labeling changes as part of the final PAS report.
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