Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
← catalyst calendarSponsored by Staar Surgical Company (industry) · STAA — their whole pipeline →.
Phase
Not applicable
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
327actual
Sites
14
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-27
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-01-30 | actual | When the study began enrolling |
| Primary completion | 2021-04-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2023-12-15 | actual | The whole study's end, after follow-up |
| First posted | 2020-02-25 | actual | When this record first appeared on the registry |
| Results posted | 2022-07-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Myopia
- Myopic Astigmatism
Intervention
- Device: EVO/EVO+ Visian ICL
Primary outcomes
what the primary-completion date above is the date OFNumber of Primary Eyes Requiring Peripheral Iridotomy (PI)
measured 6 Months
Endothelial Cell Density (ECD) Change in Primary Eyes.
measured 6 Months
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
measured 6 months
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
measured 6 months
Number of Ocular Adverse Events (AEs) in Primary Eyes.
measured 6 Months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2020-01-30 · 1.8 MB · Prot_SAP_000.pdf
Related
STAA's other studiesmost recently updated first
- Study of a Phakic Implantable Collamer Lens (ICL) Not applicable · Not yet recruiting
- Study of an Implantable Collamer Lens (ICL) Not applicable · Not yet recruiting
- Clinical Performance of a Phakic Intraocular Lens (IOL) Not applicable · Completed
- STAAR Visian Toric ICL Post-Approval Study Not applicable · Completed
- Post-Market Evaluation of the EVO ICL Not applicable · Completed
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