MyopiaEVOlveNCT06700460
Measuring Outcomes of LASIK and EVO-ICL in Matched Populations
A study testing Laser-assisted in Situ Keratomileusis and Implantable Collamer Lens placement in people with Myopia, run by Vance Thompson Vision at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Myopia
- What is being tested?
- Laser-assisted in Situ Keratomileusis and Implantable Collamer Lens placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Nov 2024to 13 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Preoperatively the Investigator will evaluate each study subject and refer to the directions for use for EVO+ ICL and Wavefront-Optimized LASIK to confirm the subject's suitability to proceed with bilateral EVO+ ICL Implantation or bilateral Wavefront-optimized LASIK in accordance with the Investigator's standard of care for each procedure. To ensure similar characteristics across study subjects, the Investigator will also adhere to the following criteria for each group:
- 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.
Who cannot join
- 1. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
- 2. Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
- 3. Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator.
- 4. Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator. For example:
- Pigment dispersion,
- History or clinical signs of iritis/uveitis,
Show all 18Show fewer
- History of previous ocular surgery,
- Monocular subjects,
- History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.),
- Evidence of retinal vascular disease,
- Keratoconus or keratoconus suspect,
- Glaucoma or glaucoma suspect by exam findings,
- Ocular surface disease other than controlled dry eye syndrome. 5. Subjects who do not qualify for both study arms:
- Bilateral Wavefront Optimized LASIK
- Bilateral EVO+ ICL implantation
- 6. Subjects who, in the judgment of the Investigator, present any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- 7. Participation in another clinical trial involving ocular procedures within the last 6-months.
- 8. Other conditions or assessment that causes the subject to not be an acceptable candidate for treatment or study participation as clinically assessed and documented by the Investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Eye Clinic
Cleveland, Ohio, 44035
Slade & Baker Vision
Houston, Texas, 77027
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
Kugler Vision
Omaha, Nebraska, 68118
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, 57108
About this study
Official title: A Randomized Evaluation of Clinical Outcomes Following Bilateral Implantation of EVO+ ICL Lenses or Bilateral Wavefront-Optimized LASIK (EVOlve)
Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
Read the detailed description
A randomized evaluation of clinical outcomes following bilateral implantation of EVO+ Visian™ Implantable Collamer™ Lenses or bilateral Wavefront-optimized LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
- Conditions
- Myopia
- Being tested
- Laser-assisted in Situ Keratomileusis, Implantable Collamer Lens placement
- Keywords
- LASIK, EVO ICL, Myopia, Clinical Outcomes
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-assisted in Situ KeratomileusisDevice
LASIK
Implantable Collamer Lens placementDevice
EVO ICL
| Study group | Role | What they receive |
|---|---|---|
| Laser-assisted in Situ Keratomileusis | Active comparator | LASIK-Wavefront Optimized Receives: Device: Implantable Collamer Lens placement |
| Implantable Collamer Lens placement | Active comparator | EVO ICL Receives: Device: Laser-assisted in Situ Keratomileusis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Uncorrected distance visual acuity and Corrected distance visual acuity
Measured: 1 month
Manifest refractive spherical equivalent
Manifest refraction spherical equivalent (MRSE) is a measurement used in eye care to determine the overall refractive error of the eye, taking into account both nearsightedness or farsightedness (spherical component) and astigmatism (cylindrical component).
It's calculated by adding the sphere power and half of the cylinder power
Measured: 1 month
Abberometry (Higher Order Abberations and Corneal Performance Index)
Aberrometry is a technique used to measure the optical aberrations of the eye, including both lower-order aberrations (LOAs) and higher-order aberrations (HOAs).
LOAs are the standard refractive errors, such as nearsightedness, farsightedness, and astigmatism, which can be corrected with glasses or contact lenses. HOAs, on the other hand, are more complex aberrations that affect the quality of vision, even if the LOAs are corrected. HOAs are caused by irregularities in the shape of the cornea or lens.
They can cause a variety of visual symptoms, including blurry vision, glare, halos, and difficulty seeing at night
Measured: 1 month
Objective Scatter Index
The Objective Scatter Index (OSI) is a measurement used in ophthalmology to assess the quality of the eye's optical media, particularly the cornea and lens.
It quantifies the amount of light scatter within the eye, which can affect visual clarity and contrast sensitivity.
Measured: 1 month
Contrast Sensitivity
Contrast sensitivity is the ability to distinguish between objects with varying degrees of contrast, especially in situations of low light or when objects have subtle differences in shading.
Measured: 1 month
Tear Film Stability
Tear film stability refers to the ability of the tear film, a thin layer of fluid that covers the surface of the eye, to remain intact and maintain a smooth, even surface. This is essential for clear vision and healthy ocular surface.
Measured: 1 month
Ocular Adverse Events in treated eyes/safety
Ocular adverse events (OAEs) are side effects that can occur in the eye after receiving a treatment, such as medication, surgery, or radiation therapy.
These events can range from mild and temporary to severe and permanent.
Measured: 1 month
Subjective Questionnaires and Open-Ended Questions
Subjective questionnaires and open-ended questions are two common methods used in research to gather qualitative data. They allow researchers to delve deeper into participants' thoughts, feelings, and experiences, providing rich insights that quantitative methods may not capture.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start27 Nov 2024
- Primary completion30 Jun 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Single group
- Model description
- All LASIK procedures in this study are to be Wavefront Optimized treatments. To ensure standardization of treatments within the LASIK cohort, Wavefront-Guided and Topography-Guided treatments are prohibited. The EX500 laser, an excimer laser, employes a 1050 Hz multidimensional active tracker, online optical pachymetry, an onboard nitrogen generator and a 500 Hz laser pulse frequency that enables the treatment of each D of myopia in 1.4 seconds. The EX500 laser will perform the wavefront refraction according to the user manual and MOP instructions. Refer to current approved EVO+ ICL Directions for Use (DFU) for surgical instructions.6 Study surgeons will use 2% HPMC OVD for EVO+ ICL surgery as recommended in the DFU.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700460
- Sponsor's protocol ID
- KJF-726
- Acronym
- EVOlve
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Per PI
Publications
Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea. 2013 Sep;32(9):1204-10. doi: 10.1097/ICO.0b013e318294b0c0.
PubMed 23846405Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology. 2003 Dec;110(12):2292-301. doi: 10.1016/j.ophtha.2002.07.001.
PubMed 14644710Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.
PubMed 15350323Directions for Use, EVO Visian® ICL (Implantable Collamer® Lens)." Accessed April 1, 2024. https://edfu.staar.com/edfu/.
Moshirfar M, Durnford K, Megerdichian A, Thomson A, Martheswaran T, West W Jr, McCabe S, Ronquillo Y, Hoopes P. Refractive Outcomes After LASIK for the Treatment of Mixed Astigmatism with the Allegretto WaveLight EX500. Ophthalmol Ther. 2022 Apr;11(2):785-795. doi: 10.1007/s40123-022-00472-4. Epub 2022 Feb 15.
PubMed 35167040U.S. Food and Drug Administration. "PMA-P030008: WAVELIGHT EXCIMER LASER SYSTEM. "Accessed.fda.gov, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030008S006. Accessed 01Apr2024.
Meidani A, Tzavara C. Comparison of efficacy, safety, and predictability of laser in situ keratomileusis using two laser suites. Clin Ophthalmol. 2016 Aug 24;10:1639-46. doi: 10.2147/OPTH.S110626. eCollection 2016.
PubMed 27601880Du H, Zhang B, Wang Z, Xiong L. Quality of vision after myopic refractive surgeries: SMILE, FS-LASIK, and ICL. BMC Ophthalmol. 2023 Jun 26;23(1):291. doi: 10.1186/s12886-023-03045-6.
PubMed 37365492
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Evaluation of Clinical Outcomes Following Bilateral Implantation of EVO+ ICL Lenses or Bilateral Wavefront-Optimized LASIK (EVOlve)
- ClinicalTrials.gov ID
- NCT06700460
- Acronym / sponsor ID
- EVOlve / KJF-726
- Conditions
- Myopia
- Keywords
- LASIK, EVO ICL, Myopia, Clinical Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 22 Nov 2024 (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.
Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
Detailed description
A randomized evaluation of clinical outcomes following bilateral implantation of EVO+ Visian™ Implantable Collamer™ Lenses or bilateral Wavefront-optimized LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All LASIK procedures in this study are to be Wavefront Optimized treatments. To ensure standardization of treatments within the LASIK cohort, Wavefront-Guided and Topography-Guided treatments are prohibited. The EX500 laser, an excimer laser, employes a 1050 Hz multidimensional active tracker, online optical pachymetry, an onboard nitrogen generator and a 500 Hz laser pulse frequency that enables the treatment of each D of myopia in 1.4 seconds. The EX500 laser will perform the wavefront refraction according to the user manual and MOP instructions. Refer to current approved EVO+ ICL Directions for Use (DFU) for surgical instructions.6 Study surgeons will use 2% HPMC OVD for EVO+ ICL surgery as recommended in the DFU.
| Arm | Type | Receives |
|---|---|---|
| Laser-assisted in Situ Keratomileusis | Active comparator | Device: Implantable Collamer Lens placementLASIK-Wavefront Optimized |
| Implantable Collamer Lens placement | Active comparator | Device: Laser-assisted in Situ KeratomileusisEVO ICL |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Preoperatively the Investigator will evaluate each study subject and refer to the directions for use for EVO+ ICL and Wavefront-Optimized LASIK to confirm the subject's suitability to proceed with bilateral EVO+ ICL Implantation or bilateral Wavefront-optimized LASIK in accordance with the Investigator's standard of care for each procedure. To ensure similar characteristics across study subjects, the Investigator will also adhere to the following criteria for each group:
Key exclusion criteria (18 listed)
- 1. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
- 2. Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
- 3. Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator.
- 4. Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator. For example:
- 6. Subjects who, in the judgment of the Investigator, present any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
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 |
|---|---|---|
| Laser-assisted in Situ KeratomileusisLASIK | Device | Implantable Collamer Lens placement |
| Implantable Collamer Lens placementEVO ICL | Device | Laser-assisted in Situ Keratomileusis |
Primary outcome
Visual Acuity
Time frame: 1 month
Uncorrected distance visual acuity and Corrected distance visual acuity
Manifest refractive spherical equivalent
Time frame: 1 month
Manifest refraction spherical equivalent (MRSE) is a measurement used in eye care to determine the overall refractive error of the eye, taking into account both nearsightedness or farsightedness (spherical component) and astigmatism (cylindrical component). It's calculated by adding the sphere power and half of the cylinder power
Abberometry (Higher Order Abberations and Corneal Performance Index)
Time frame: 1 month
Aberrometry is a technique used to measure the optical aberrations of the eye, including both lower-order aberrations (LOAs) and higher-order aberrations (HOAs). LOAs are the standard refractive errors, such as nearsightedness, farsightedness, and astigmatism, which can be corrected with glasses or contact lenses. HOAs, on the other hand, are more complex aberrations that affect the quality of vision, even if the LOAs are corrected. HOAs are caused by irregularities in the shape of the cornea or lens. They can cause a variety of visual symptoms, including blurry vision, glare, halos, and difficulty seeing at night
Objective Scatter Index
Time frame: 1 month
The Objective Scatter Index (OSI) is a measurement used in ophthalmology to assess the quality of the eye's optical media, particularly the cornea and lens. It quantifies the amount of light scatter within the eye, which can affect visual clarity and contrast sensitivity.
Contrast Sensitivity
Time frame: 1 month
Contrast sensitivity is the ability to distinguish between objects with varying degrees of contrast, especially in situations of low light or when objects have subtle differences in shading.
Tear Film Stability
Time frame: 1 month
Tear film stability refers to the ability of the tear film, a thin layer of fluid that covers the surface of the eye, to remain intact and maintain a smooth, even surface. This is essential for clear vision and healthy ocular surface.
Ocular Adverse Events in treated eyes/safety
Time frame: 1 month
Ocular adverse events (OAEs) are side effects that can occur in the eye after receiving a treatment, such as medication, surgery, or radiation therapy. These events can range from mild and temporary to severe and permanent.
Subjective Questionnaires and Open-Ended Questions
Time frame: 1 month
Subjective questionnaires and open-ended questions are two common methods used in research to gather qualitative data. They allow researchers to delve deeper into participants' thoughts, feelings, and experiences, providing rich insights that quantitative methods may not capture.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 23846405Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea. 2013 Sep;32(9):1204-10. doi: 10.1097/ICO.0b013e318294b0c0.
- Background: PubMed 14644710Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology. 2003 Dec;110(12):2292-301. doi: 10.1016/j.ophtha.2002.07.001.
- Background: PubMed 15350323Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.
- BackgroundDirections for Use, EVO Visian® ICL (Implantable Collamer® Lens)." Accessed April 1, 2024. https://edfu.staar.com/edfu/.
- Background: PubMed 35167040Moshirfar M, Durnford K, Megerdichian A, Thomson A, Martheswaran T, West W Jr, McCabe S, Ronquillo Y, Hoopes P. Refractive Outcomes After LASIK for the Treatment of Mixed Astigmatism with the Allegretto WaveLight EX500. Ophthalmol Ther. 2022 Apr;11(2):785-795. doi: 10.1007/s40123-022-00472-4. Epub 2022 Feb 15.
- BackgroundU.S. Food and Drug Administration. "PMA-P030008: WAVELIGHT EXCIMER LASER SYSTEM. "Accessed.fda.gov, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030008S006. Accessed 01Apr2024.
- Background: PubMed 27601880Meidani A, Tzavara C. Comparison of efficacy, safety, and predictability of laser in situ keratomileusis using two laser suites. Clin Ophthalmol. 2016 Aug 24;10:1639-46. doi: 10.2147/OPTH.S110626. eCollection 2016.
- Background: PubMed 37365492Du H, Zhang B, Wang Z, Xiong L. Quality of vision after myopic refractive surgeries: SMILE, FS-LASIK, and ICL. BMC Ophthalmol. 2023 Jun 26;23(1):291. doi: 10.1186/s12886-023-03045-6.
- Individual participant dataSharing planned: No. Per PI
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser-assisted in Situ Keratomileusis and Implantable Collamer Lens placement in people with Myopia, run by Vance Thompson Vision at 5 sites in United States.
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 8 inclusion and 18 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: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06700460, which also lists 8 linked publications.
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 17 Jul 2026.