Wavefront-guided vs. Optimized LASIK for Myopia

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Thin corneas, Keratoconus, Autoimmune, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.

Who Is on the Research Team?

Edward E. Manche, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 21 with healthy eyes who have nearsightedness ranging from very mild to severe (-0.25 to -11.00 diopters), with or without astigmatism up to 5.00 diopters. It's not suitable for those with certain eye conditions like keratoconus, pregnant or nursing individuals, people under 21, those with thin corneas, significant differences in vision between eyes, or autoimmune diseases.

Inclusion Criteria

Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters

I am 21 or older with healthy eyes.

Exclusion Criteria

I am under 21 years old.

My corneas are very thin.

Patients with more than 1.5 diopter difference in astigmatism between eyes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo bilateral simultaneous LASIK surgery with either wavefront-guided or wavefront-optimized laser

1 day

1 visit (in-person)

Post-operative care

Participants receive topical antibiotics and ophthalmic drops for one week following the procedure

1 week

1 visit (in-person) on post-op day one

Follow-up

Participants are monitored for safety and effectiveness at one month, three months, six months, and one year after surgery

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Resolution Wavefront-guided LASIK
• Wavefront Optimized LASIK

Trial Overview The study is examining the effectiveness of two types of LASIK surgery: one using a high definition wavefront-guided laser and the other using a wavefront-optimized laser. The goal is to see which method provides better results for correcting nearsightedness and astigmatism.

How Is the Trial Designed?

Group I: iDesign WFG LASIK Active Control 1 Intervention

Wavefront-guided LASIK

Group II: Wavelight WFO LASIK Active Control 1 Intervention

Wavefront-optimized LASIK

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+