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| General |
| Study Status |
Ongoing |
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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| 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 |
| Interim Results |
No unanticipated AEs or deaths caused by or associated with subject device to date (page 15)
During this reporting period:
- subject 09-032 had 20.9% ECD loss (Endothelial cell density (ECD) =20% of baseline reported as AEs). Follow-up microscopy performed after 7 months demonstrated 22.4% ECD loss concluding that it was initial cell loss due to procedure. Therefore, there does not appear to be new concerns pertaining to ECD decline.
-One case of clinically significant ASC cataract in fellow eye of Subject 03-007 at the Year 2 postoperative visit. Given relatively well-preserved visual acuity in this case, cataract surgery has not been entertained.
- Subjects 03-007 and 03-022 reported to have developed asymptomatic ASC opacity in the primary eye during this reporting period.
Current reporting period has 24 new AEs (table 8):
4 Dry eye
4 Vitreous detachment
4 Chalazion
1 Corneal endothelial cell loss
1 IOL repositioning
1 IOL exchange
2 glare/halo
1 Iris transillumination defect
1 Vitreous floater
2 Blepharitis
1 Lens rotation
1 astigmatism
1 epirtinal membrane
Out of the above 24 new AEs, there are 6 new SAE
- Subject 02-014, 2 SAEs: residual refractive astigmatism and LASIK enhancement
- Subject 10-038, 2 SAEs: Lens rotation and lens repositioning
- Subject 10-038, 2 SAEs: Lens rotation and lens exchange
Table 10 lists all SAEs up to date (page 20-21)
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| Actual Number of Patients Enrolled |
327 subjects (629 eyes)
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| Actual Number of Sites Enrolled |
All 14 sits from pre-approval study are participating
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| Patient Follow-up Rate |
All 327 subjects (629 eyes) have undergone surgery in 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
82 eyes (86.3%) available for year 3 analysis
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| Final Effect Findings |
Firm updated (page 31) tables for the following 3 effectiveness endpoints, which I cannot put in here but copied over in the space below.
MRSE within +/- 1.00 D of target
MRSE within +/- 0.50 D of target
UDVA of 20/40 or better (for those eyes with CDVA 20/20 or better at Preoperative Visit)
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