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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of LASIK eye surgery to improve vision for individuals with nearsightedness (difficulty seeing far away) and possibly astigmatism (blurred vision due to an irregularly shaped cornea). Researchers aim to determine if a high-definition wavefront-guided laser (High Resolution Wavefront-guided LASIK) yields better outcomes than a wavefront-optimized laser (Wavefront Optimized LASIK). Individuals who have been nearsighted for some time and do not have conditions like thin corneas or certain disorders may qualify. The goal is to identify which laser provides clearer vision and better eye health. As an unphased trial, this study offers participants the chance to contribute to advancing LASIK technology for improved vision outcomes.

Do I need to stop my current medications for the LASIK trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that these LASIK techniques are safe for treating myopia?

Research has shown that both types of LASIK surgery, wavefront-guided and wavefront-optimized, are safe for people with nearsightedness. Studies have found that wavefront-guided LASIK effectively improves vision. Patients have reported good results, and the procedure is generally well-tolerated.

Wavefront-optimized LASIK also maintains a strong safety record. Reports indicate that this type of LASIK reliably improves vision. The FDA has approved it, confirming its safety for treating vision issues.

Both treatments have a good safety history, with no major side effects reported in the research. This should reassure anyone considering joining a clinical trial for these LASIK methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these LASIK treatments for myopia because they offer precision and customization beyond traditional methods. High Resolution Wavefront-guided LASIK uses advanced imaging to map the eye’s surface in detail, allowing for a personalized correction that addresses unique visual imperfections. On the other hand, Wavefront Optimized LASIK focuses on maintaining natural corneal shape, which can enhance night vision and reduce glare. These innovative approaches aim to improve overall visual quality and patient satisfaction compared to standard LASIK procedures.

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

This trial will compare High Resolution Wavefront-guided LASIK with Wavefront Optimized LASIK for treating myopia. Studies have shown that both wavefront-guided and wavefront-optimized LASIK effectively treat nearsightedness. Research indicates that wavefront-guided LASIK often results in better vision, improving vision quality and more effectively reducing issues like glare and halos. However, wavefront-optimized LASIK is also recognized for its safety and effectiveness. While both treatments perform well, wavefront-guided LASIK might offer slightly better visual quality. ^{1 2 4 5 6}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8481996/

PMC - PubMed Central WFG and NWFG FS-LASIK are both effective and safe procedures to correct low & moderate and high myopia, but WFG FS-LASIK gives a better postoperative MEI, ...

2. aaojournal.org aaojournal.org/article/S0161-6420(08)00355-2/fulltext

Wavefront-Guided LASIK for the Correction of Primary ... Published Results. The data from published studies and PMA reports reviewed indicate that WFG LASIK exceeds established guidelines for safety and effectiveness.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025002479

Ray tracing-guided LASIK for high myopia and astigmatism Ray tracing-guided LASIK demonstrated favorable safety, efficacy and predictability for high myopia and astigmatism in this study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10676645/

Comparison of the 1st Generation and 3rd ... In this study, we compare the visual, refractive, and patient-reported outcomes of the 1st generation wavefront-guided treatment (CustomVue with ...

5. precisionvisionlondon.com precisionvisionlondon.com/wavefront-guided-vs-wavefront-optimised-lasik-which-gives-better-vision/

Wavefront-Guided vs Wavefront-Optimised LASIK Research and clinical studies show wavefront-guided LASIK can achieve better visual results than wavefront-optimised treatments.

6. aao.org aao.org/education/editors-choice/better-visual-outcomes-seen-with-wavefront-guided-

Better visual outcomes seen with wavefront-guided LASIK ... This prospective randomized study compared visual outcomes following wavefront-guided LASIK (WFG-LASIK) performed in one eye and small incision lenticule ...