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

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment EVO-ICL for near-sightedness?

Research shows that the EVO-ICL is effective for correcting a wide range of vision problems, including myopia (nearsightedness), with high levels of clear vision after surgery and stable results over time. Studies involving thousands of eyes have demonstrated its safety and effectiveness, making it a reliable option for improving vision. ^{1 2 3 4 5}

Is the EVO-ICL safe for correcting vision problems?

The EVO-ICL has been shown to be safe for correcting vision problems, with studies reporting low rates of complications like cataracts and high patient satisfaction. Safety data from thousands of eyes indicate improved safety compared to earlier models, making it a reliable option for vision correction. ^{5 6 7 8 9}

How does the EVO-ICL treatment differ from LASIK for near-sightedness?

EVO-ICL involves implanting a special lens inside the eye, which can provide better night vision and more stable vision correction compared to LASIK, which reshapes the cornea with a laser. Unlike LASIK, EVO-ICL does not require removing any corneal tissue and is reversible. ^{1 2 3 4 10}

Eligibility Criteria

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)

I am considered suitable for EVO+ ICL or LASIK eye surgery after evaluation.

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

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

My dry eye syndrome can't be managed with eye drops or medication.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of visual quality after EVO-ICL implantation and SMILE to select the appropriate surgical method for high myopia. [2020]

2. England pubmed.ncbi.nlm.nih.gov

EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Visual outcomes after small incision lenticule extraction and implantable collamer lens V4c for moderate myopia: 1-year results. [2021]

4. United States 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. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Safety of phakic intraocular collamer lens implantation in 95 highly myopic special-needs children. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Traumatic cataract and other adverse events with the implantable contact lens. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Phakic intraocular lenses outcomes and complications: Artisan vs Visian ICL. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Intraocular Implantable Collamer Lens with a Central Hole Implantation: Safety, Efficacy, and Patient Outcomes. [2023]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

[Comparison of the two methods, LASIK and ICL in mild and high hyperopia correction--part one]. [2007]