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NCT Number: NCT07790965

Study of a Phakic Implantable Collamer Lens (ICL)

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

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Phakic Implantable Collamer Lens (ICL)

Device

Diffractive Trifocal Phakic ICL

Primary outcomes

  1. Cumulative and Persistent Adverse Events

    Time frame: 3 Months

    Safety Population

Other outcomes

  1. Rates of Secondary Surgical Interventions

    Time frame: 3 Months

    Safety Population

  2. Frequency and Proportion of Eyes With Visual Symptoms

    Time frame: 3 Months

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

  3. Frequency and Proportion of Eyes With Ocular and Visual Symptoms

    Time frame: 3 Months

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

  4. Uncorrected Distance Visual Acuity

    Time frame: 3 Months

    Safety Population - Mean Change and Mean Difference

  5. Uncorrected Intermediate Visual Acuity

    Time frame: 3 Months

    Safety Population - Mean Change and Mean Difference

  6. Uncorrected Near Visual Acuity

    Time frame: 3 Months

    Safety Population - Mean Change and Mean Difference

  7. Best Corrected Distance Visual Acuity

    Time frame: 3 Months

    Safety Population - Mean Change and Mean Difference

  8. Distance Corrected Intermediate Visual Acuity

    Time frame: 3 Months

    Safety Population - Mean Change and Mean Difference

  9. Distance Corrected Near Visual Acuity

    Time frame: 3 Months

    Safety Population - Mean Change and Mean Difference

  10. Mean Monocular Contrast Sensitivity

    Time frame: 3 Months

    Safety Population

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

    Time frame: 3 Months

    Safety Population

  12. Subjective Visual Quality

    Time frame: 3 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Lynch

CONTACT

[email protected]

Laura Director, Clinical Affairs

CONTACT

[email protected]

336-306-0587

Sponsors and collaborators

Lead sponsor

Staar Surgical Company

Industry

Registry information

Official study title

Proof of Concept Study of a Diffractive Trifocal Phakic Implantable Collamer Lens (ICL) in Presbyopes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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