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NCT04283149 · ClinicalTrials.gov registry record · NA
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)
A NA study, sponsored by Staar Surgical Company.
- Completed
- Registry status
- NA
- Development phase
- 327
- Enrollment target
NCT04283149: Completed NA study, sponsored by Staar Surgical Company.
NCT04283149 is a NA study that has completed, run by Staar Surgical Company. The registered enrollment target is 327 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04283149, a NA study, has completed, sponsored by Staar Surgical Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 327 participants
- Enrollment target
Study Summary
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.
Primary Outcome
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.
Interventions
- DEVICE EVO/EVO+ Visian ICL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2023-12-15 |
| Phase | NA |
What the finished NCT04283149 record still lists
NCT04283149 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which EVO/EVO+ Visian ICL is the first listed.
NCT04283149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04283149 about?
NCT04283149 is a clinical study titled "Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)". This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary ...
What is the current status of trial NCT04283149?
This trial is currently completed. It is a NA study. The enrollment target is 327 participants. The study started on 2020-01-30. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT04283149?
The interventions under investigation include: EVO/EVO+ Visian ICL (DEVICE).
Who is sponsoring clinical trial NCT04283149?
This trial is sponsored by Staar Surgical Company, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04283149's enrollment target sits among peer trials
327 309th of 2000 higher than 1,691 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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