RecruitingNot Applicable

Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

United States56 participantsStarted 2024-11-27

Plain-language summary

Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.

Who can participate

Age range

21 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects ages 21 to 45 years old.
. Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.
. Myopia or myopia with astigmatism with spherical equivalent ranging from -3.00 D to ≤ -8.00 D (in the spectacle plane) and cylinder in the range of 0.00 D to 4.00 D (in the spectacle plane).
. Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.
. Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D.
. Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
. Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Acuity

Timeframe: 1 month

Manifest refractive spherical equivalent

Timeframe: 1 month

Abberometry (Higher Order Abberations and Corneal Performance Index)

Timeframe: 1 month

Objective Scatter Index

Timeframe: 1 month

Contrast Sensitivity

Timeframe: 1 month

Tear Film Stability

Timeframe: 1 month

Ocular Adverse Events in treated eyes/safety

Timeframe: 1 month

Subjective Questionnaires and Open-Ended Questions

Timeframe: 1 month

Trial details

NCT IDNCT06700460

SponsorVance Thompson Vision

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

Contact for this trial

Kristin L Dunne

1-877-522-3937 kristin.dunne@vancethompsonvision.com

View on ClinicalTrials.gov More Myopia trials

Who can participate

Age range

21 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects ages 21 to 45 years old.
. Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.
. Myopia or myopia with astigmatism with spherical equivalent ranging from -3.00 D to ≤ -8.00 D (in the spectacle plane) and cylinder in the range of 0.00 D to 4.00 D (in the spectacle plane).
. Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.
. Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D.
. Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
. Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.

What they're measuring

Visual Acuity

Timeframe: 1 month

Manifest refractive spherical equivalent

Timeframe: 1 month

Abberometry (Higher Order Abberations and Corneal Performance Index)

Timeframe: 1 month

Objective Scatter Index

Timeframe: 1 month

Contrast Sensitivity

Timeframe: 1 month

Tear Film Stability

Timeframe: 1 month

Ocular Adverse Events in treated eyes/safety

Timeframe: 1 month

Subjective Questionnaires and Open-Ended Questions

Timeframe: 1 month