Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes.
Dan Z Reinstein, Timothy J Archer, Marine Gobbe
https://pubmed.ncbi.nlm.nih.gov/26605350/Actively Recruiting
Led by Hoopes Vision · Updated on 2025-10-01
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating a new form of LASIK called Ray Tracing Guided LASIK by comparing it to three other types of corneal refractive surgery KeratoLenticule Extraction KLEx using the Zeiss Visumax 800 Laser, Wavefront Optimized LASIK WFO LASIK using the Alcon EX500 Laser, and Topography Guided LASIK Contoura LASIK also using the Alcon EX500 Laser. The study focuses on patients with myopia or myopia with astigmatism and aims to compare visual outcomes across these different technologies in a prospective, randomized design. This study is conducted in three phases, each including at least 44 participants who undergo surgery for refractive correction. In each phase, patients will have one eye treated with Ray Tracing Guided LASIK and the other eye treated with one of the three comparator procedures. The surgeries use specific laser devices and technologies tailored to each method. Participants will receive routine postoperative care and medications as per standard practices. Participants will attend follow-up visits at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. At several visits, including screening and postoperative timepoints, patients will complete questionnaires about their experience. Researchers will measure uncorrected visual acuity at 3, 6, and 12 months as the main outcome. Additional assessments include predictability of vision correction. Retreatments are allowed only after all study visits are completed or the subject has left the study.
CONDITIONS
A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
S
Steven H Linn, OD
S
Shealynn Petersen, BS
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Hoopes Vision
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Ray-Tracing Guided LASIK | Keratorefractive Lenticule Extraction (KLEx) | Wavefront or Topography Guided LASIK |
|---|---|---|---|
| What it is | A LASIK procedure that uses advanced ray tracing technology to design a personalized excimer laser treatment profile aimed at correcting refractive error more precisely. | A minimally invasive refractive surgery that creates and removes a small lens-shaped section (lenticule) from the cornea with a femtosecond laser, reshaping the eye to correct myopia or myopic astigmatism. | LASIK using either a wavefront-optimized or topography-guided approach: the first aims to reduce new optical distortions (spherical aberration), while the second uses corneal shape mapping to personalize the laser profile for vision correction. |
| Role in trial | Used to treat one eye in each participant across multiple randomized arms for direct comparison with other modern refractive technologies. | Serves as an active comparator, being randomly assigned to one eye in select study arms for head-to-head analysis of visual outcomes. | Active comparator technology: participants receive either a wavefront-optimized or topography-guided procedure in one eye, depending on arm assignment, for comparison with Ray-Tracing LASIK. |
| Primary use | Correction of myopia or myopic astigmatism in adults seeking laser vision correction using a highly customized, ray-tracing based surgical plan. | Correction of myopia or myopic astigmatism by minimally invasive removal of a corneal lenticule, providing an alternative to flap-based laser surgery. | Surgical correction of myopia or myopic astigmatism by reshaping the cornea based on wavefront analysis or topography mapping to optimize post-surgical vision quality. |
| How it is performed | An individualized surgical plan is created by tracing light as it passes through the entire eye, guiding precise excimer laser ablation to reshape the cornea. Usually performed as outpatient day surgery. | A femtosecond laser creates a customized lens-shaped section within the cornea. This thin lenticule is removed through a small incision, without making a large corneal flap. | An excimer laser precisely reshapes the cornea, guided by pre-surgery wavefront (total optical system) analysis or topographic (corneal mapping) data. A thin flap is created and lifted, then the laser reshapes the corneal surface. |
| Evidence status | There is emerging evidence for highly personalized ray-tracing guided laser ablation, but most published refractive surgery outcome literature focuses on other established LASIK profiles; large-scale or long-term outcome evidence for this method is still developing. | Multiple high-quality studies support the effectiveness of KLEx/SMILE for myopia and myopic astigmatism, with visual outcomes comparable to femtosecond LASIK and good predictability for target refraction. | Wavefront-optimized and topography-guided LASIK are supported by broad published evidence, achieving high rates of target vision and reducing higher-order optical aberrations in patients with myopia/myopic astigmatism. |
| Important limitations | Long-term outcome and complications data for personalized ray-tracing guided LASIK are limited, as this approach is not yet as widely adopted or studied as other refractive surgery methods. | Potential limitations of KLEx/SMILE include higher cost, the need for specialized lasers, and limited suitability for correcting very high astigmatism; some report slightly slower initial visual recovery compared to LASIK. | Limitations include dependence on high-quality imaging data for laser planning, risk of under/overcorrection, possible development of dry eye or glare, and device/operator variability. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery
Participants undergo refractive correction surgery using one of the four different refractive technologies on each eye, followed by standard postoperative care.
1 surgical visit (in-person)
Duration - 12 months
Participants return for scheduled postoperative visits to monitor healing and visual outcomes, and to complete questionnaires about their experience.
6 visits: 1-day, 1-week, 1-month, 3-month, 6-month, and 12-month (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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Lead Sponsor