70 Participants Needed

LASIK Surgery for Near-sightedness

EE
Overseen ByEdward E Manche, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of LASIK eye surgeries to determine which is more effective for treating nearsightedness. Participants will receive wavefront-guided LASIK on one eye and ray tracing-guided LASIK on the other. The trial seeks individuals aged 22 and older with healthy eyes, nearsightedness, similar vision in each eye, and manageable levels of astigmatism (blurred vision due to an irregularly shaped cornea). It is not suitable for those with eye diseases such as glaucoma or cataracts. As an unphased trial, it offers participants the opportunity to contribute to advancements in LASIK technology and improvements in future eye care.

Will I have to stop taking my current medications?

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

What prior data suggests that these LASIK techniques are safe?

Studies have shown that both wavefront-guided and ray tracing-guided LASIK treatments are generally safe for correcting nearsightedness.

For wavefront-guided LASIK, research indicates it is very safe and effective. One study found that almost all patients achieved 20/20 vision or better after one year, and the procedure also improved night vision.

Ray tracing-guided LASIK also demonstrates strong safety results. In one study, it was safe and effective for correcting nearsightedness, with or without astigmatism, and many patients achieved vision better than 20/20.

Both treatments are well-tolerated and have reliably improved vision.12345

Why are researchers excited about this trial?

Researchers are excited about these LASIK techniques for near-sightedness because they offer more personalized vision correction. Wavefront-guided LASIK uses detailed measurements of your eye's unique imperfections to tailor the laser treatment, potentially improving visual outcomes beyond standard LASIK. Ray tracing-guided LASIK takes this a step further by using advanced technology to map how light travels through the eye, aiming to enhance precision and accuracy in one eye, compared to wavefront-guided treatment in the other. These cutting-edge methods could lead to sharper, clearer vision and reduce common issues like glare and halos, making them a promising advancement over traditional LASIK options.

What evidence suggests that this trial's LASIK procedures could be effective for near-sightedness?

This trial will compare wavefront-guided LASIK and ray tracing-guided LASIK for treating near-sightedness. Research has shown that wavefront-guided LASIK is highly effective, with 92% of individuals achieving 20/20 vision and 99% achieving 20/40 vision or better. Long-term results indicate that nearly everyone maintained excellent vision for at least four years. Ray tracing-guided LASIK also shows promise. It is considered safe and effective, with half of the treated individuals achieving vision sharper than 20/20. Most participants reported clear distance vision and no issues with near vision. Both methods hold strong potential for improving vision in those with near-sightedness.13456

Who Is on the Research Team?

EE

Edward E Manche, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals aged 22 or older with nearsightedness between -1.00 and -10.00 diopters, and up to 3.00 diopters of astigmatism in each eye, who have similar levels of nearsightedness in both eyes. Participants must not have abnormal corneal shapes, excessively thin corneas, or eye diseases like glaucoma or cataracts.

Inclusion Criteria

I am 22 years old or older.
My nearsightedness is between -1.00 and -10.00 diopters.
My nearsightedness is about the same in both eyes.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preoperative Examination

Eligible participants are examined preoperatively to establish a baseline for ocular condition

1 week
1 visit (in-person)

Treatment

Participants undergo wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye

1 day
1 visit (in-person)

Postoperative Evaluation

Participants undergo an ophthalmic evaluation at regular intervals to monitor outcomes

12 months
Multiple visits (in-person) at 1, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Multiple visits (in-person) at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • LASIK

Trial Overview

The study compares two types of LASIK surgery: wavefront-guided LASIK on one eye and ray tracing-guided LASIK on the other eye for each participant to determine which method is more effective at correcting vision.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Wavefront-guided laser ablationActive Control1 Intervention
Group II: Ray tracing-guided LASIKActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

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.

Refractive outcome and visual quality of Ray-Tracing Guided ...

This study aimed to evaluate the safety and effectiveness of Ray-Tracing Guided LASIK surgery and to compare the refractive outcomes and visual ...

Ray-tracing–guided myopic LASIK: real-world clinical...

Ray-trace based LASIK was safe and effective for correction of myopia with and without astigmatism. Approximately, half the eyes achieved ≥20/12.5 UDVA and 8% ...

Ray-tracing-guided FS-LASIK: Refractive outcomes, Visual ...

In terms of subjective visual quality, 100% of patients reported clear distance vision, and 96.10% had no near-reading difficulty. Investigation ...

Ray-tracing–guided myopic LASIK: real-world clinical ...

001). Conclusions: Ray-trace based LASIK was safe and effective for correction of myopia with and without astigmatism. Approximately, half ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37595291/

Ray-tracing-guided myopic LASIK: real-world clinical ...

Ray-trace based LASIK was safe and effective for correction of myopia with and without astigmatism. Approximately, half the eyes achieved ≥20/12.5 UDVA and 8% ...