LASIK vs ICL for Near-sightedness

(EVOlve Trial)

Recruiting at 5 trial locations

Overseen By Kristin L Dunne

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Vance Thompson Vision

Disqualifiers: Pregnancy, Uncontrolled diabetes, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two eye surgeries to improve vision for individuals with near-sightedness (myopia), with or without blurry vision from astigmatism. It compares the outcomes of LASIK, a laser eye surgery, and EVO-ICL, which involves placing a special lens inside the eye. The goal is to determine which method more effectively corrects or reduces vision problems. Ideal participants are those with stable near-sightedness for at least a year. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future vision correction options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to get a clear answer based on your specific situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both EVO-ICL and LASIK are generally safe methods for correcting near-sightedness. Studies indicate that EVO-ICL is well-tolerated. A five-year study found that the EVO-ICL lens effectively corrected high levels of near-sightedness and was safe to use. This lens also features a central opening that helps reduce eye pressure, enhancing its safety.

Regarding LASIK, studies report that serious complications are rare, occurring in only about 0.07% of cases. Most patients express satisfaction with their results, and the procedure is known for its safety and effectiveness. Long-term studies confirm that LASIK provides stable improvements in vision.

Both treatments have strong safety records based on past research, making them good options for those considering corrective eye surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for near-sightedness because they each offer unique benefits compared to traditional methods like glasses or contact lenses. LASIK, short for Laser-assisted in Situ Keratomileusis, uses a precise laser to reshape the cornea, which can quickly improve vision and is typically a one-time procedure. On the other hand, the Implantable Collamer Lens (EVO-ICL) involves placing a special lens inside the eye, which can be removed or upgraded if necessary, offering a reversible and adjustable solution. Both options aim to reduce dependency on corrective lenses, but EVO-ICL stands out by not altering the corneal tissue, potentially preserving more of the eye's natural structure.

What evidence suggests that this trial's treatments could be effective for near-sightedness?

This trial will compare two treatments for nearsightedness: EVO-ICL and LASIK. Studies have shown that EVO-ICL effectively improves vision for people with myopia, with 95% of patients achieving 20/20 vision or better without glasses after the procedure. One study found that EVO-ICL improved vision in 93.3% of cases. Meanwhile, LASIK is a well-established treatment for myopia, with about 88.3% of patients experiencing excellent vision results. Long-term research confirms that LASIK provides stable and positive improvements in vision. Both treatments reliably enhance eyesight in those with nearsightedness. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with near-sightedness, possibly also having astigmatism, who are seeking vision correction. Specific eligibility criteria details were not provided.

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either bilateral implantation of EVO+ ICL lenses or bilateral Wavefront-optimized LASIK for the correction or reduction of myopia with or without astigmatism

1 month

Multiple visits for procedure and initial assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of visual acuity, contrast sensitivity, and ocular adverse events

1 month

Regular follow-up visits for assessments

Long-term Follow-up

Participants may be monitored for long-term outcomes and stability of vision correction

Additional months as needed

What Are the Treatments Tested in This Trial?

Interventions

• EVO-ICL
• LASIK

Trial Overview The study compares two types of vision correction procedures: LASIK, a laser surgery reshaping the cornea; and EVO-ICL placement, where a lens is implanted inside the eye.

How Is the Trial Designed?

Group I: Implantable Collamer Lens placement Active Control 1 Intervention

EVO ICL

Group II: Laser-assisted in Situ Keratomileusis Active Control 1 Intervention

LASIK-Wavefront Optimized

Who Is Running the Clinical Trial?

Vance Thompson Vision

Lead Sponsor

Trials

11

Recruited

300+

Published Research Related to This Trial

In a study involving 68 highly myopic eyes from 34 patients, both Artisan and Visian ICL phakic intraocular lenses demonstrated comparable safety and visual outcomes after one year, with no significant differences in uncorrected or corrected distance visual acuity.

Both types of lenses effectively reduced the mean preoperative spherical equivalent from around -12.5 diopters to near zero, indicating their efficacy in correcting high myopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phakic intraocular lenses outcomes and complications: Artisan vs Visian ICL. Hassaballa, MA., Macky, TA.[2021]

In a study involving 48 eyes for each surgical method, EVO-ICL implantation showed slightly better postoperative visual quality compared to SMILE for patients with high myopia (-6.25 to -10 D).

Post-surgery, the SMILE group experienced a decrease in visual quality parameters, such as modulation transfer function (MTF) values, while the EVO-ICL group maintained better visual outcomes three months after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of visual quality after EVO-ICL implantation and SMILE to select the appropriate surgical method for high myopia. Qin, Q., Bao, L., Yang, L., et al.[2020]

The EVO and EVO+ Visian Implantable Collamer Lenses (ICL) are effective options for correcting myopia and myopic astigmatism, with studies showing excellent safety and visual outcomes for patients.

The EVO+ lens, with its larger optical diameter, offers improved night vision quality compared to the standard EVO lens, making it a preferable choice for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism. Martínez-Plaza, E., López-de la Rosa, A., López-Miguel, A., et al.[2023]

The implantation of the implantable contact lens (ICL) for high myopia or hyperopia is generally safe, with no significant decrease in crystalline lens transparency or increase in lens density observed in younger patients, and good visual outcomes reported.

However, older patients or those with preexisting lens opacities showed a higher incidence of anterior subcapsular opacities and clinically significant cataracts, indicating that these factors may increase the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic cataract and other adverse events with the implantable contact lens. Sarikkola, AU., Sen, HN., Uusitalo, RJ., et al.[2022]

In a study comparing LASIK and ICL procedures for hyperopia correction involving 57 eyes from 33 patients, ICL implantation resulted in significantly better uncorrected visual acuity (UCVA) and more stable postoperative refraction over time compared to LASIK.

While both procedures improved UCVA postoperatively, LASIK showed a tendency for worsened best-corrected visual acuity (BCVA) compared to preoperative values, whereas ICL maintained or improved BCVA, indicating ICL may be a safer and more effective option for hyperopia correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of the two methods, LASIK and ICL in mild and high hyperopia correction--part one]. Horáková, M., Vlková, E., Loukotová, V., et al.[2007]

In a study of 67 eyes from 39 patients, both the EVO-ICL and SMILE procedures showed good safety and efficacy for correcting moderate myopia, with no complications reported after one year.

While both procedures had similar visual outcomes, patients reported different subjective visual complaints: halos were more common after ICL implantation, while blurred vision was more frequently reported after SMILE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual outcomes after small incision lenticule extraction and implantable collamer lens V4c for moderate myopia: 1-year results. Aruma, A., Li, M., Choi, J., et al.[2021]

Phakic intraocular lens (ICL) implantation, particularly with the newer EVO/EVO+ models, demonstrated excellent efficacy with a weighted average efficacy index of 1.03 and a safety index of 1.19 over an average follow-up of 24.7 months in a study involving 3399 eyes.

The procedure showed a low incidence of complications, such as elevated intraocular pressure and cataracts, while significantly improving both quality of vision and quality of life for patients, making it a strong alternative to laser vision correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraocular Implantable Collamer Lens with a Central Hole Implantation: Safety, Efficacy, and Patient Outcomes. Wannapanich, T., Kasetsuwan, N., Reinprayoon, U.[2023]

In a study comparing 164 LASIK and 164 ICL procedures for correcting myopia, the ICL showed significantly better outcomes in best spectacle-corrected visual acuity (BSCVA) at 6 months, with 95% achieving 20/20 vision compared to 85% for LASIK.

The ICL also demonstrated superior safety and predictability, with a lower rate of vision loss and higher stability in refractive outcomes, making it a promising alternative to LASIK for treating myopia in the specified range.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. Sanders, DR.[2022]

In a study of 95 special-needs children with high ametropia who underwent intraocular collamer lens (ICL) implantation, the overall adverse event (AE) rate was low, with only 2% experiencing minor AEs and 4% facing major AEs, primarily postoperative pupillary block.

The mean follow-up period of 2 years showed that endothelial cell loss was comparable to that seen in adults, indicating that ICL implantation can be a safe option for children, even those with neurodevelopmental disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of phakic intraocular collamer lens implantation in 95 highly myopic special-needs children. Reynolds, M., Hoekel, J., Tychsen, L.[2023]

The EVO Implantable Collamer Lens (ICL) has been shown to be safe and effective for correcting a wide range of refractive errors, based on data from 67 studies involving 1,905 eyes with an average follow-up of 12.5 months.

Safety data indicate that the EVO ICL has lower rates of complications, such as anterior subcapsular cataract and pupillary block, compared to earlier models, making it a favorable choice for both patients and surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implantable Collamer Lens with a central port: review of the literature. Packer, M.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10787571/

A Comprehensive Retrospective Analysis of EVO/EVO+ ... Among eyes that were correctable to 20/20 preoperatively, 95% achieved 20/20 or better without correction postoperatively and 99% of eyes ...

2. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-023-03050-9

Four-year visual outcomes and optical quality of SMILE and ... SMILE and EVO-ICL implantation provided safe and effective correction of high myopia. SMILE showed slightly better long-term predictability.

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1543864/full

Subjective and objective changes in visual quality after ... Comparison of visual outcomes after non-toric and toric implantable collamer lens V4c for myopia and astigmatism. Acta Ophthalmol. (2021) 99 ...

4. journals.lww.com journals.lww.com/ijo/fulltext/2025/01000/visual_outcomes_with_implantable_collamer_lens.21.aspx

Visual outcomes with implantable Collamer lens versus ... The efficacy for SMILE was 83.3% and that for ICL was 93.3%. Safety and predictability (±0.5D) for both was 100%. A significant increase was observed in ocular ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9738966/

The EVO ICL for Moderate Myopia: Results from the US FDA ... Recently, authors have reported predictable, stable, safe, and effective results in low myopia and myopic astigmatism.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12534635/

Real-World Safety Profile of EVO and EVO+ Implantable ... Five-year outcomes of EVO implantable collamer lens implantation for the correction of high myopia and super high myopia. Eye Vis Lond. 2021 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030016S035B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The study was a multicenter prospective single-arm study to evaluate the safety, and to collect supportive data concerning the effectiveness of ...

8. dovepress.com dovepress.com/clinical-outcomes-of-implantable-collamer-lenses-for-the-treatment-of--peer-reviewed-fulltext-article-OPTH

Clinical Outcomes of Implantable Collamer Lenses for the ... This single center study demonstrates that ICL surgery in American eyes with ACDs < 3.0 mm may also be safe and result in excellent outcomes.

9. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.780000/full

Two-Year Visual Outcomes of Evolution Implantable ... In recent years, few studies have also reported that EVO-ICL demonstrated good efficacy and safety in correcting low to moderate myopia (13, 14) ...

10. eyewiki.org eyewiki.org/Implantable_Collamer_Lens

Implantable Collamer Lens There is also safety data showing that the central port allowing for physiologic flow through the optic reduces the rate of anterior ...