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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study of an Aspheric Optic Phakic Implantable Collamer Lens (ICL)
- ClinicalTrials.gov ID
- NCT07791381
- Acronym / sponsor ID
- CP26-01
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Staar Surgical CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-labeled, single-site study of an implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants bilaterally implanted with an implantable collamer lens (ICL) | Experimental | Device: Implantable collamer lens (ICL)Participants will receive an implantable collamer lens (ICL) in each eye |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be between the age of 21 - 60 years,
- Must be suitable for ICL surgery,
- Must meet all unique study eligibility criteria
Key exclusion criteria (3 listed)
- Outside the age of 21 - 60 years,
- Not a suitable candidate for ICL surgery,
- Does not meet all unique study eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable collamer lens (ICL)ICL with aspheric optic | Device | Participants bilaterally implanted with an implantable collamer lens (ICL) |
Primary outcome
Cumulative and Persistent Adverse Events
Time frame: 3 Months
Safety Population
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Schall contact
Gabriel Quesada Larez, MD principal investigator
Clinica Quesada SA de CV
Questions about this trial
What is this clinical trial studying?
A study testing Implantable collamer lens (ICL) in people with Myopia and Astigmatism, run by Staar Surgical Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Director, Clinical Operations (585-749-7910, jlynch@staar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative and Persistent Adverse Events (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.