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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P030016 S035/ PAS002 |
| Date Original Protocol Accepted |
05/20/2022
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| Date Current Protocol Accepted |
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| Study Name |
CP22-01 Postmarket Evaluation of the EVO ICL
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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 |
This new enrollment, prospective, multi-center, single arm PAS study will be conducted at up to 10 clinical sites in the United States (US). The study is designed to evaluate the success of the EVO Physician Certification Program in reducing the rate of early IOP increases at 1 – 6 hours after implantation of EVO/EVO+ ICL lenses by surgeons who have been trained and certified under the EVO Physician Certification Program.
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| Study Population |
Subjects aged 21 to 45 years implanted with EVO/EVO+ ICLs in both eyes, in accordance with the product labeling and the eligibility criteria.
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| Sample Size |
The study will enroll a minimum 200 subjects (i.e., 200 primary eyes and 200 fellow eyes).
Assumptions include:
• The proportion of primary eyes that will reach or exceed an IOP of 30 mmHg is 6% and the proportion of primary eyes that will reach or exceed an IOP of 40 mmHg is 1%. These estimates are based on Study CP19-01 data (as presented in PMA P030016/S035) from investigators who followed the instructions in the proposed EVO Physician Certification Program regarding removal of OVD, i.e., used a minimum of 10 – 20 cc of irrigation solution.
• The proportion of fellow eyes reaching these thresholds for increased IOP will be equivalent to the rates found in the primary eyes.
• No more than 10% loss to follow-up in this 2-week study.
For a single sample exact binomial test with a two-tailed alpha of 0.05 to demonstrate that a hypothesized rate of 6% is significantly lower than 15.3% for IOP spikes = 30 mmHg with 98% power, a sample of 181 eyes would be required. Demonstrating that the rate of IOP spikes greater than or equal to 40 mmHg is significantly lower, given a hypothesized rate of 1% vs the Study CP19-01 rate of 7%, a sample size of 181 primary eyes of 181 subjects will achieve 96% power. Power to achieve both endpoints can be conservatively estimated by the product of the two powers, .98 times .96, or 94%. Analysis of fellow eye rates would also be conducted, and results would be used to support the findings of the two primary eye analyses.
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| Key Study Endpoints |
The primary endpoint is the proportion of primary (i.e., first implanted) eyes that have IOP greater than or equal to 30 mmHg and IOP greater than or equal to 40 mmHg at 1 – 6 hours postoperatively.
The secondary endpoint is the proportion of fellow eyes that have IOP greater than or equal to 30 mmHg and IOP greater than or equal to 40 mmHg at 1 – 6 hours postoperatively.
Other safety endpoints include the following:
1) the proportion of fellow eyes that have IOP greater than or equal to 30 mmHg at 1 - 6 hours postoperatively
2) the proportion of fellow eyes that have IOP greater than or equal to 40 mmHg at 1 - 6 hours postoperatively
3) Rates of increased IOP in primary and all (primary + fellow) eyes attributed to retained OVD
4) Rates of increased IOP in primary and all eyes attributed to other causes (e.g., pupillary block, steroid response, etc.)
5) Rates of all categories of AEs (in primary and in all eyes)
6) Device deficiencies
7) Distribution of lens vault measured by OCT
8) Slit lamp findings and distributions of gradings (e.g., of anterior chamber cells and flare)
9) Notable ophthalmoscopy findings
10) UDVA and CDVA (uncorrected and corrected distance visual acuity)
11) Instances of loss of greater than or equal to 10 letters of CDVA from baseline, along with analyses of the causes.
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| Follow-up Visits and Length of Follow-up |
Length of follow-up will be two weeks post-implantation of the fellow eye
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
205
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| Actual Number of Sites Enrolled |
8
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| Patient Follow-up Rate |
The Applicant reports that 402 of 408 eyes were available for analysis at Visit 4 (for each eye), 10-18 days after surgery. The 6 eyes not available were categorized as "Missing at scheduled visit but seen earlier/later," meaning 0 eyes were lost to follow-up.
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| Final Safety Findings |
The primary study endpoint was the proportion of primary (i.e., first implanted) eyes that had Intraocular Pressure (IOP) greater than (or equal to) 30 mmHg, and greater than (or equal to) 40 mmHg at 1-6 hours postoperatively. The analysis of the primary study endpoint was based on the superiority of the proportion of primary eyes that have IOP greater than (or equal to) 30 mmHg and IOP greater than (or equal to) 40 mmHg at 1 – 6 hours postoperatively compared with the outcomes of Study CP19-01 (IDE G191084), which reported 15.3% (50/327) primary eyes with IOP greater than (or equal to) 30 mmHg, and 7.0% (23/327) primary eyes with IOP greater than (or equal to) 40 mmHg. In the current study, 7.3% (15/205) and 2.0% (4/205) of primary eyes presented with IOP greater than (or equal to) 30 mmHg and IOP greater than (or equal to) 40 mmHg, respectively, at the 1-6 hour postoperative visit. Based on these results, the incidence of IOP greater than (or equal to) 30 mmHg and IOP greater than (or equal to) 40 mmHg in primary eyes is significantly lower than that reported in Study CP19-01.
The secondary study endpoint is the proportion of fellow eyes that had IOP greater than (or equal to) 30 mmHg and greater than (or equal to) 40 mmHg at 1-6 hours postoperatively. Per protocol, analysis of fellow eye rates was used to support the findings of the two primary eye analyses. In the current study, 7.9% (16/203) and 3.0% (6/203) of fellow eyes presented with IOP greater than (or equal to) 30 mmHg and IOP greater than (or equal to) 40 mmHg, respectively, at the 1-6 hour postoperative visit. Based on these results, the incidence of IOP greater than (or equal to) 30 mmHg and IOP greater than (or equal to) 40 mmHg in fellow eyes is significantly lower than that reported in original PMA Study CP19-01.
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| Final Effect Findings |
The objective of this clinical trial was to assess the rate of early Intraocular Pressure (IOP) increases following implantation of EVO ICL lenses compared to Study CP19-01 (IDE G191084). Data that were analyzed relating to effectiveness included accuracy of refractive correction and visual acuity outcomes during the postoperative follow-up (10-18 days after surgery). The Manifest Refraction Spherical Equivalent (MRSE) was within 0.50 Diopters (D) in 84.6% (345/408) and within 1.00 D in 98.5% (402/408) of all eyes at Visit 4 (10-18 days). In addition, 99.8% (407/408) of eyes with preoperative Corrected Distance Visual Acuity (CDVA) 20/20 or better achieved Uncorrected Distance Visual Acuity (UDVA) 20/40 or better and 96.6% (394/408) of eyes reported no change or improvement of CDVA at Visit 4 (10-18 days) compared with preoperative values. These outcomes are comparable with those observed in pre-approval Study CP19-01.
The accuracy of refractive correction, achievement of high levels of UDVA with preservation of CDVA with EVO ICL lenses are comparable to the early postoperative results achieved in Study CP19-01.
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| Study Strengths & Weaknesses |
All study endpoints were met, all milestones were achieved, and no subjects were lost to follow-up. The majority of protocol deviations were minor, and appropriate corrective actions were introduced for major deviations. All adverse events were categorized as anticipated.
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| Recommendations for Labeling Changes |
None.
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