LASIK vs SMILE Eye Surgery for Vision Correction

Overseen By Michele R Avila, OD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Hoopes Vision

Disqualifiers: Dry eye, Irregular astigmatism, Keratoconus, Corneal dystrophies, Herpetic keratitis, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of eye surgeries, LASIK (Topography Guided LASIK Surgery) and SMILE (Small Incision Lenticule Extraction Surgery), to determine which provides better vision results post-surgery. Participants will undergo LASIK on one eye and SMILE on the other to directly compare outcomes. The trial seeks individuals with stable nearsightedness (difficulty seeing distant objects) or nearsightedness with astigmatism, who have good overall eye health and achieve 20/20 vision or better with glasses or contacts. As an unphased trial, it offers participants the chance to directly contribute to advancements in eye surgery techniques.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, contact lens wearers must stop using hard or gas permeable lenses for at least 4 weeks and soft lenses for at least 5 days before the preoperative screening.

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

Research has shown that both SMILE and Topography-Guided LASIK surgeries are safe options for improving vision. Studies indicate that SMILE is effective and generally well-received. Long-term research has found it safe for correcting high levels of nearsightedness. The risk of suction loss, a potential issue during surgery, is rare, occurring in only 0.17% to 5.06% of cases.

Topography-Guided LASIK also maintains a strong safety record. Studies report that most people achieve 20/20 vision or better after the procedure. Complications are uncommon, with issues like flap folds occurring in only 0.73% of cases. Serious vision problems are even rarer, affecting just 0.07% of eyes.

In summary, both procedures are considered safe with a very low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these vision correction surgeries because they offer unique benefits over traditional options like standard LASIK. Topography-Guided LASIK uses precise mapping of the eye's surface to tailor the procedure for each patient, potentially improving outcomes and reducing side effects like glare. Meanwhile, Small Incision Lenticule Extraction (SMILE) is a minimally invasive technique that uses a tiny incision, which may promote faster recovery and maintain the eye's structural integrity better than larger incisions. These advancements could lead to more personalized and efficient treatments for correcting vision.

What evidence suggests that this trial's treatments could be effective for vision correction?

This trial will compare Small Incision Lenticule Extraction (SMILE) and Topography-Guided LASIK for vision correction. Research has shown that SMILE effectively improves vision, particularly for individuals with myopia, or nearsightedness. Studies indicate that SMILE is safe, reliable, and often results in high patient satisfaction, typically causing less dry eye than other surgeries.

Topography-Guided LASIK has also demonstrated excellent results, with many studies reporting that all patients achieve 20/20 vision or better without glasses. This LASIK method uses a detailed map of the eye's surface for more precise correction. Both treatments in this trial have strong evidence supporting their effectiveness in enhancing vision. ^{1 2 3 6 7}

Who Is on the Research Team?

Majid Moshirfar, MD

Principal Investigator

Hoopes Vision

Are You a Good Fit for This Trial?

This trial is for people aged 22-50 with near-sightedness or astigmatism, having a stable prescription that hasn't changed much in the last year. They should not have had previous eye surgeries, significant dry eyes, keratoconus, or certain other eye conditions. Pregnant women and those with uncontrolled diabetes or autoimmune diseases are excluded.

Inclusion Criteria

I am between 22 and 50 years old.

My eyesight prescription has been stable for the last year.

BCVA of 20/20 or better in each eye

Exclusion Criteria

I am not pregnant, breastfeeding, nor plan to become pregnant during the study.

I do not have uncontrolled diabetes, unstable blood pressure, or unstable autoimmune conditions.

The Principal Investigator has determined the subject not to be a good candidate for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo refractive correction surgery with either Topography-Guided LASIK or Small Incision Lenticule Extraction

1 day

1 visit (in-person)

Postoperative Care

Participants receive postoperative care instructions and medications following standard of care practices

1 week

1 visit (in-person)

Follow-up

Participants are monitored for visual outcomes and safety at 1-day, 1-week, 1-month, 3-month, and 12-month visits

12 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Small Incision Lenticule Extraction Surgery
• Topography Guided LASIK Surgery

Trial Overview The study compares visual outcomes of two types of laser eye surgery: Topography Guided LASIK on one eye and Small Incision Lenticule Extraction on the other. Each participant receives both procedures, one per eye, to see which provides better vision postoperatively.

How Is the Trial Designed?

Group I: Topography-Guided LASIK Active Control 1 Intervention

Subjects receive Topography-Guided LASIK surgery on one eye.

Group II: Small Incision Lenticule Extraction Active Control 1 Intervention

Subjects receive Small Incision Lenticule Extraction surgery on one eye.

Who Is Running the Clinical Trial?

Hoopes Vision

Lead Sponsor

Trials

1

Recruited

40+

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK549896/

Small Incision Lenticule Extraction - StatPearls - NCBI Bookshelf Known as Refractive Lenticule Extraction (RLE), SMILE demonstrates advantages such as increased patient satisfaction and reduced postoperative dry eye. Despite ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8403850/

Five-year results of refractive outcomes and vision-related ... In the present study, in a long-term follow-up we demonstrate that correcting high myopia with SMILE is safe, effective, and predictable.

3. nature.com nature.com/articles/s41598-025-98041-9

Comparison of clinical outcomes following small incision ... Outcomes were assessed at a 3-month follow-up, including standard visual outcomes, optic zone decentration, and corneal higher-order aberrations ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.1100241/full

Efficacy of small-incision lenticule extraction surgery in ... Conclusion: This meta-analysis suggests that SMILE, FS-LASIK, and T-PRK show excellent efficacy, predictability, and safety for myopia. SMILE exhibited less ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S216209892500088X

Asia-Pacific Journal of Ophthalmology Several studies have reported effective and safe outcomes of SMILE combined with monovision. Fu et al. reported uncorrected distance visual acuity (UDVA) of all ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0377123721002239

Small incision lenticule extraction (SMILE) refractive surgery SMILE surgery shows excellent safety, predictability, and efficacy. Presently, LASIK and its equivalent flap-based refractive surgeries are not recommended for ...

7. aao.org aao.org/eye-health/treatments/what-is-small-incision-lenticule-extraction

What Is Small Incision Lenticule Extraction? Small incision lenticule extraction (SMILE) is a newer type of laser refractive surgery. This kind of surgery uses a laser to treat myopia ...