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Not yet recruitingNCT07791381Updated Aug 27, 2026

Study of an Implantable Collamer Lens (ICL)

An interventional study of Implantable collamer lens (ICL) in Myopia and Astigmatism, sponsored by Staar Surgical Company. Not yet recruiting. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Staar Surgical Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years to 60 Years
Sex
All
01

Study summary

A prospective, open-labeled, single-site study of an implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism.

02

Conditions studied

  • Myopia
  • Astigmatism
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 10 is below the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Staar Surgical Company is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be between the age of 21 - 60 years,
  • Must be suitable for ICL surgery,
  • Must meet all unique study eligibility criteria

Exclusion criteria

Exclusion Criteria:

  • Outside the age of 21 - 60 years,
  • Not a suitable candidate for ICL surgery,
  • Does not meet all unique study eligibility criteria
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Participants bilaterally implanted with an implantable collamer lens (ICL)

    Participants will receive an implantable collamer lens (ICL) in each eye

    Device: Implantable collamer lens (ICL)

Interventions

  • DeviceImplantable collamer lens (ICL)

    ICL with aspheric optic

06

What researchers measure

Primary outcomes

  1. Cumulative and Persistent Adverse Events

    Safety Population

    Time frame: 3 Months

Other outcomes

  1. Rates of Secondary Surgical Interventions

    Safety Population

    Time frame: 3 Months

  2. Frequency and Proportion of eyes with visual symptoms

    Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire

    Time frame: 3 Months

  3. The frequency and proportion of eyes with ocular and visual symptoms

    Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire

    Time frame: 3 Months

  4. Uncorrected Distance Visual Acuity

    Safety Population - Mean Change and Mean Difference

    Time frame: 3 Months

  5. Uncorrected Intermediate Visual Acuity

    Safety Population - Mean Change and Mean Difference

    Time frame: 3 Months

  6. Uncorrected Near Visual Acuity

    Safety Population - Mean Change and Mean Difference

    Time frame: 3 Months

  7. Best Corrected Distance Visual Acuity

    Safety Population - Mean Change and Mean Difference

    Time frame: 3 Months

  8. Distance Corrected Intermediate Visual Acuity

    Safety Population - Mean Change and Mean Difference

    Time frame: 3 Months

  9. Distance Corrected Near Visual Acuity

    Safety Population - Mean Change and Mean Difference

    Time frame: 3 Months

  10. Mean monocular contrast sensitivity

    Safety Population

    Time frame: 3 Months

  11. Defocus Curves from +1.0 D through -3.0 D defocus

    Safety Population

    Time frame: 3 Months

  12. Subjective Visual Quality

    Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire

    Time frame: 3 Months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's planned 6 months is close to that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2026
First posted
Aug 27, 2026
StartEst.
Nov 2026
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07791381
Lead sponsor
Staar Surgical Company
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Nov 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Jennifer Director, Clinical Operations
Contact
jlynch@staar.com
585-749-7910
Laura Schall
Contact
lschall@staar.com
Gabriel Quesada Larez, MD
principal investigator · Clinica Quesada SA de CV

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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