Ray-Tracing Guided LASIK for Near-sightedness and Astigmatism

Overseen By Shealynn Petersen, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Hoopes Vision

Disqualifiers: Dry eye, Irregular astigmatism, Corneal dystrophies, Herpetic keratitis, others

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

Compensation: Varies

Number of Visits: 4

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a new LASIK method, Ray Tracing Guided LASIK, with three other eye surgeries to assist individuals with near-sightedness (difficulty seeing far away) and astigmatism (blurred vision due to an irregularly shaped cornea). Participants will undergo different combinations of these surgeries in each eye to determine which method is most effective. Individuals diagnosed with near-sightedness or near-sightedness with astigmatism, who have had stable vision for at least a year, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative eye surgery techniques and contribute to advancements in vision correction.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, contact lens wearers must stop using their lenses for a certain period before the preoperative screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Ray-Tracing Guided LASIK is safe and effective for improving vision in individuals with nearsightedness and astigmatism. Most patients achieved excellent vision, with many seeing better than 20/20.

Keratorefractive Lenticule Extraction, another treatment under study, has also proven safe. Long-term results indicate that it maintains stable vision, with no loss of clarity.

WaveFront Optimized LASIK is well-researched. Studies confirm its high safety and effectiveness for correcting nearsightedness and astigmatism, providing stable and predictable results.

Topography Guided LASIK is another safe option. Research supports its success, showing low complication rates and reliable vision correction.

These treatments have demonstrated good safety records, making them promising options for those considering vision correction surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Ray-Tracing Guided LASIK because it offers a personalized approach to correcting near-sightedness and astigmatism. Unlike traditional LASIK, which uses a standard laser pattern, Ray-Tracing Guided LASIK precisely maps the eye's unique shape and imperfections, allowing for a more tailored and potentially more effective correction. This method aims to enhance visual outcomes and reduce common side effects like halos or glare. By focusing on individual eye characteristics, this technique could represent a significant advancement over existing options like conventional LASIK or PRK, promising better vision quality for patients.

What evidence suggests that this trial's treatments could be effective for near-sightedness and astigmatism?

This trial will compare different LASIK techniques for correcting nearsightedness and astigmatism. Research has shown that Ray-Tracing Guided LASIK, one of the techniques being tested, is safe and effective, with about half of the treated eyes achieving excellent vision (20/12.5 or better) without major complications. Another technique under study, Keratorefractive Lenticule Extraction (KLEx), demonstrated great long-term results for nearsightedness, maintaining stable vision for over 13 years and showing strong visual and refractive outcomes shortly after surgery. Wavefront Optimized LASIK, also part of this trial, is known for its effectiveness and safety across various levels of nearsightedness, with many studies supporting its success. Lastly, Topography Guided LASIK, another technique being evaluated, has proven highly accurate in correcting vision, with most eyes achieving precise results. ^{1 2 3 6 7}

Who Is on the Research Team?

Majid Moshirfar, MD

Principal Investigator

Hoopes Vision

Are You a Good Fit for This Trial?

This trial is for individuals with near-sightedness or astigmatism who are seeking corrective eye surgery. Participants should be suitable candidates for refractive surgery, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Preop Spherical component of ≥ -2.00 and ≤ -8.00 D

Refractive Cylinder of ≤ -3.00 D

BCVA of 20/20 or better in each eye (83 or more letters on the ETDRS Chart)

Exclusion Criteria

History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease

The Principal Investigator has determined the subject not to be a good candidate for the study

My eye condition affects the shape of my cornea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants undergo Ray-Tracing LASIK or KLEx surgery

1 day

1 visit (in-person)

Treatment Phase 2

Participants undergo Ray-Tracing LASIK or WFO LASIK surgery

1 day

1 visit (in-person)

Treatment Phase 3

Participants undergo Ray-Tracing LASIK or Topography Guided LASIK surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

1-day, 1-week, 1-month, 3-month, 6-month, and 12-month visits

What Are the Treatments Tested in This Trial?

Interventions

• Keratorefractive Lenticule Extraction (KLEx)
• Ray-Tracing Guided LASIK
• Topography Guided LASIK
• WaveFront Optimized LASIK

Trial Overview The study compares Ray-Tracing Guided LASIK to three other corneal surgeries: KLEx using Zeiss Visumax 800 Laser, WFO LASIK with Alcon EX500 Laser, and Topography Guided LASIK (Contoura) also with the Alcon EX500. It's a contralateral comparison where each patient receives different treatments on each eye.

How Is the Trial Designed?

Group I: ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS Active Control 2 Interventions

Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Keratorefractive Lenticule Extraction in the LEFT EYE

Group II: ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD Active Control 2 Interventions

Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Keratorefractive Lenticule Extraction in the RIGHT EYE

Group III: ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS Active Control 2 Interventions

Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Wavefront Optimized LASIK in the LEFT EYE.

Group IV: ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD Active Control 2 Interventions

Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Wavefront Optimized LASIK in the RIGHT EYE

Group V: ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS Active Control 2 Interventions

Subjects receive Ray Tracing Guided in the RIGHT EYE and Topography Guided LASIK in the LEFT EYE

Group VI: ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD Active Control 2 Interventions

Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Topography Guided LASIK in the RIGHT EYE

Who Is Running the Clinical Trial?

Hoopes Vision

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12367364/

Thirteen-Year Outcomes of Keratorefractive Lenticule ... Purpose: To explore the long-term (13-year) outcomes associated with keratorefractive lenticule extraction (KLEx) among patients with myopia up to −10 dioptres.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1888429625000196

Postoperative visual outcomes with lenticule extraction in ... The procedure resulted in excellent visual and refractive outcomes, with high predictability and stability from 1-week to 1-year postoperative follow-ups.

3. nature.com nature.com/articles/s41598-024-73303-0

The outcomes of first-generation (visumax 500) and ... The first KLEx group demonstrated greater residual astigmatism than did the second KLEx group throughout the three-month follow-up period.

4. aaojournal.org aaojournal.org/article/S0161-6420(24)00724-3/fulltext

Evidence-Based Guidelines for Keratorefractive Lenticule ... Cyclotorsion compensation significantly improved postoperative outcomes with lower indices of success (MD, −0.05 [95% CI, −0.08 to −0.03; P < 0.001]) and ...

5. dovepress.com dovepress.com/comparing-the-existing-myopic-keratorefractive-lenticule-extraction-kl-peer-reviewed-fulltext-article-OPTH

Comparing The Existing Myopic Keratorefractive Lenticule ... All platforms demonstrated excellent cylindrical correction, as over 87% of eyes achieved outcomes within ± 0.50 D. HOAs increased across all ...

6. dovepress.com dovepress.com/initial-visual-and-refractive-outcomes-of-keratorefractive-lenticule-e-peer-reviewed-fulltext-article-OPTH

Initial Visual and Refractive Outcomes of Keratorefractive ... The present study confirms the refractive stability with minimal changes (− 0.04D relative to the intended target) over 3 months of follow up.

7. journals.healio.com journals.healio.com/doi/10.3928/1081597X-20250204-03

Keratorefractive Lenticule Extraction for Myopia and Myopic ... Accuracy of spherical equivalent to intended target showed 95.1% of eyes were within ±0.50 D and 99.6% were within ±1.00 D for spherical ...