MyopiaNCT07791381
Study of an Implantable Collamer Lens (ICL)
A study testing Implantable collamer lens (ICL) in people with Myopia and Astigmatism, run by Staar Surgical Company.
Trial summary
A prospective, open-labeled, single-site study of an implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Implantable collamer lens (ICL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be between the age of 21 - 60 years,
- Must be suitable for ICL surgery,
- Must meet all unique study eligibility criteria
Who cannot join
- Outside the age of 21 - 60 years,
- Not a suitable candidate for ICL surgery,
- Does not meet all unique study eligibility criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Laura Schall contact
About this study
Official title: Proof of Concept Study of an Aspheric Optic Phakic Implantable Collamer Lens (ICL)
A prospective, open-labeled, single-site study of an implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism.
- Conditions
- Myopia, Astigmatism
- Being tested
- Implantable collamer lens (ICL)
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable collamer lens (ICL)Device
ICL with aspheric optic
| Study group | Role | What they receive |
|---|---|---|
| Participants bilaterally implanted with an implantable collamer lens (ICL) | Experimental | Participants will receive an implantable collamer lens (ICL) in each eye Receives: Device: Implantable collamer lens (ICL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative and Persistent Adverse Events
Safety Population
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staar Surgical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Quesada Larez, MD, Principal investigator, Clinica Quesada SA de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791381
- Sponsor's protocol ID
- CP26-01
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No