|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210005 / PAS001 |
| Date Original Protocol Accepted |
09/20/2022
|
| Date Current Protocol Accepted |
|
| Study Name |
Continuation Study - SAIL-101-PAS
|
| Device Name |
IC-8 Apthera Intraocular Lens (IOL)
|
| Clinical Trial Number(s) |
NCT03633695
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: To evaluate the long-term safety of the IC-8 Apthera IOL.
Design:
Structure: Prospective, multi-center, open-label, single-group, post-approval follow-up study of subjects previously implanted with the IC-8 Apthera IOL in the IC-8 Apthera IOL IDE study (G180075).
Sites: 21 U.S. clinical sites that participated in the IC-8 Apthera IOL IDE study.
Duration: Approximately 18 months to allow for 12 months of enrollment and 6 months to conduct the 3-year post IC-8 Apthera IOL implantation visit.
Administration: There is no active treatment in this study.
Visit Schedule: All subjects will undergo one scheduled visit: the 3-year post IC-8 Apthera IOL implantation visit.
|
| Study Population |
The study population will include patients previously implanted with the IC-8 Apthera IOL in the IC-8 Apthera IOL IDE study (G180075).
There are no Exclusion criteria for this study. All subjects that participated in the US IDE (G180075) are intended to be reconsented to participate in this study.
Subjects are eligible for the study if they meet the following Inclusion criteria:
Inclusion Criteria:
1. Enrolled in IDE G180075 study and implanted with the IC-8 Apthera IOL;
2. Able to comprehend and have signed a statement of informed consent;
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)
|
| Sample Size |
No. of subjects: All 343 IC-8 Apthera IOL subjects are intended to be re-consented.
Sample size is based on the number of subjects who participated in the pivotal study G180075.
No. of sites: 21
Sites location: US
|
| Key Study Endpoints |
Co-Primary Safety Endpoints:
• Rates of secondary surgical interventions (pars plana vitrectomy, explant, laser treatment, etc.)
• Rates of other serious adverse events (as described in ISO 11979-7 historical grid)
• Rates of ocular adverse events, including but not limited to the adverse events described in the ISO 11979-7 historical grid
• Rates of subjective visual disturbances
Additional Safety Endpoints:
Other parameters that will be collected and evaluated for safety in the study include but are not limited to the following:
• Monocular best-corrected distance visual acuity (BCDVA)
• Rate of IOL removals
|
| Follow-up Visits and Length of Follow-up |
1 visit at year 3.
Total length of follow-up: 3 years
|
| Interim or Final Data Summary |
| Interim Results |
No serious adverse events. There are a total of 8 mild and moderate adverse events reported.
|
| Actual Number of Patients Enrolled |
154
|
| Actual Number of Sites Enrolled |
21
|
| Patient Follow-up Rate |
45% (154/343) of subjects had been enrolled in this PAS. 10 subjects are reported as lost to follow-up.
|
