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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.

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.

What data supports the effectiveness of LASIK and SMILE eye surgery for vision correction?

Research shows that both SMILE and LASIK are effective for correcting vision problems like myopia (nearsightedness) and astigmatism (blurred vision due to an irregularly shaped cornea). Studies comparing the two treatments indicate that they have similar visual and refractive outcomes, meaning they both improve vision effectively. ^{1 2 3 4 5}

Is LASIK or SMILE eye surgery safe for vision correction?

Both LASIK and SMILE are generally considered safe for vision correction, with SMILE showing high safety and stable outcomes in long-term studies. SMILE may have fewer issues with dry eyes post-surgery and is preferred for those who play contact sports, but it can have complications like suction loss and incision tears, which are manageable without loss of vision. ^{6 7 8 9 10}

How does SMILE eye surgery differ from other vision correction treatments?

SMILE (Small Incision Lenticule Extraction) is unique because it is a minimally invasive procedure that uses a single laser to correct vision, unlike LASIK which involves creating a flap in the cornea. SMILE is performed through a small incision, which may result in less trauma to the eye and potentially fewer complications like dry eye compared to LASIK. ^{1 4 5 11 12}

Research Team

Majid Moshirfar, MD

Principal Investigator

Hoopes Vision

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

References

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

Topography-guided photorefractive keratectomy for irregular astigmatism after small incision lenticule extraction. [2014]

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

Control-matched comparison of refractive and visual outcomes between small incision lenticule extraction and femtosecond laser-assisted LASIK. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Visual outcomes of early enhancement following small incision lenticule extraction versus laser in situ keratomileusis. [2023]

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

Dry eye disease after refractive surgery: comparative outcomes of small incision lenticule extraction versus LASIK. [2022]

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

Refractive lenticule extraction (ReLEx) through a small incision (SMILE) for correction of myopia and myopic astigmatism: current perspectives. [2022]

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

Postoperative Corneal Complications in Small Incision Lenticule Extraction: Long-Term Study. [2019]

7. China pubmed.ncbi.nlm.nih.gov

History and Results; Indications and Contraindications of SMILE Compared With LASIK. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

[Experience with Introduction of SMILE: Learning Phase of our First 200 Treatments]. [2017]

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

Safety and complications of more than 1500 small-incision lenticule extraction procedures. [2022]

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

Visual outcomes after SMILE from the first-year experience at a U.S. military refractive surgery center and comparison with PRK and LASIK outcomes. [2021]

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

Unwanted Astigmatism and High-order Aberrations One Year after Excimer and Femtosecond Corneal Surgery. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Two-years results of small-incision lenticule extraction and wavefront-guided laser in situ keratomileusis for Myopia. [2022]