Search > Astigmatism
62 Participants NeededMy employer runs this trial

SMILE vs LASIK for Near-sightedness

EE
Overseen ByEdward E Manche, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Stanford University
Disqualifiers: Under 22, Thin corneas, Keratoconus, Autoimmune diseases, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Participants will undergo LASIK surgery in one eye using ray tracing guided technology in one eye and LASIK surgery in the other eye using wavefront guided technology. We are comparing outcomes between the two technologies as measured by self reported quality of vision and quality of life outcomes using validated questionnaires before and after surgery. We will also be comparing outcomes between the two technologies including measurement of low contrast visual acuity,and best spectacle corrected visual acuity.

Are You a Good Fit for This Trial?

This trial is for adults age 22 or older with healthy eyes, nearsightedness between -1.00 and -8.00 diopters, and up to 3.00 diopters of astigmatism in both eyes (with similar vision levels in each eye). People with certain eye diseases, very thin corneas, autoimmune diseases, or who are pregnant/nursing cannot join.

Inclusion Criteria

I am nearsighted between -1.00 and -8.00 diopters.
I am 22 years old or older and my eyes are healthy.
I have 3.00 diopters or less of astigmatism.

Exclusion Criteria

I have been diagnosed with keratoconus based on eye scans.
I have an eye disorder that causes my eye to be abnormally enlarged or stretched.
My corneas are very thin.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person), 1 visit (telephone)

Preoperative Assessment

Participants undergo preoperative assessment to establish a baseline for ocular condition

1 week
1 visit (in-person)

Treatment

Participants undergo bilateral LASIK and SMILE surgery for the correction of myopia

1 day
1 visit (in-person)

Postoperative Follow-up

Participants are monitored for safety and effectiveness after surgery, including ophthalmic evaluations at regular intervals

3 months
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ray tracing guided LASIK surgery

Trial Overview

The study compares two types of LASIK surgery: ray tracing-guided LASIK in one eye versus wavefront-guided LASIK in the other eye of the same person. Researchers will measure vision quality and life impact before and after surgery using questionnaires and visual tests.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Ray tracing guided LASIK surgeryActive Control1 Intervention
Group II: SMILE surgeryActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.