Effect of 3 excimer laser ablation frequencies (200 Hz, 500 Hz, 1000 Hz) on the cornea using a 1000 Hz scanning-spot excimer laser.
Ramin Khoramnia, Chris P Lohmann, Christian Wuellner...
https://pubmed.ncbi.nlm.nih.gov/20656164Actively Recruiting
Phase Not Applicable
Age: 22Years - 50Years
All Genders
Healthy Volunteers
ID07201298
A Prospective Contralateral Comparison of Ray-Tracing Guided LASIK (WaveLight Plus LASIK) vs. Small Incision Lenticule Extraction (SMILE Pro) Using VisuMax 800, or Wavefront Optimized LASIK or Topography Guided LASIK (Contoura LASIK): A Three-Phase Visual Outcomes Study.
Led by Hoopes Vision · Updated on 2025-10-01
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
Who Can Participate
Age: 22Years - 50Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 22-50 at the time of consent
- Diagnosis of myopia or myopia with astigmatism with preoperative spherical equivalent refraction between -2.00 and -9.00 diopters
- Preoperative spherical component between -2.00 and -8.00 diopters
- Refractive cylinder of 0.00 through -3.00 diopters
- Best corrected visual acuity of 20/20 or better in each eye
- Stable refraction with change no greater than 0.50 diopters over at least 12 months
- Contact lens wearers must discontinue soft lenses for at least 5 days and hard or gas-permeable lenses for at least 4 weeks before screening
- Acceptable preoperative tomography and examination results as determined by the investigator
- Surgical plan targeting emmetropia in both eyes with no monovision
- Willing and able to use postoperative medications as prescribed
- Ability to complete all preoperative and postoperative questionnaires, tests, and visits
- Willingness and ability to return for all postoperative examinations
You will not qualify if you...
- Clinically significant dry eye on examination
- Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography
- History of corneal dystrophies or guttata
- History of herpetic keratitis or active disease
- Previous refractive surgery
- History of glaucoma or glaucoma suspect
- Uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Investigator determines subject is not a good candidate for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Implementation
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)
Post-operative Follow-up
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)
Trial Site Locations
Total: 1 location
1
Hoopes Moshirfar Research Center
Draper, Utah, United States, 84020
Actively Recruiting
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Research Team
S
Steven H Linn, OD
S
Shealynn Petersen, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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Published Research Related To This Trial
Comparison of different excimer laser ablation frequencies (50, 200, and 500 Hz).
C Winkler von Mohrenfels, R Khoramnia, C-P Lohmann
https://pubmed.ncbi.nlm.nih.gov/19597838Comparison of efficacy, safety, and predictability of laser in situ keratomileusis using two laser suites.
Alexandra Meidani, Chara Tzavara
https://pubmed.ncbi.nlm.nih.gov/27601880Wavefront-optimized ablation profiles: theoretical background.
Michael Mrochen, Christof Donitzky, Christian Wüllner...
https://pubmed.ncbi.nlm.nih.gov/15093638Influence of corneal curvature on calculation of ablation patterns used in photorefractive laser surgery.
M Mrochen, T Seiler
https://pubmed.ncbi.nlm.nih.gov/11583235Comparison of Clinical Outcomes and Patient Satisfaction Following SMILE Performed With the VisuMax 800 in One Eye and VisuMax 500 in the Contralateral Eye.
Sri Ganesh, Sheetal Brar, Deepak T Swamy
https://pubmed.ncbi.nlm.nih.gov/39783817Refractive and Visual Outcomes of SMILE for Compound Myopic Astigmatism With the VISUMAX 800.
Dan Z Reinstein, Timothy J Archer, Joseph G Potter...
https://pubmed.ncbi.nlm.nih.gov/37162399Comparison of the visual results after small incision lenticule extraction and femtosecond laser-assisted LASIK for myopia.
Miguel A Teus, Montserrat Garcia-Gonzalez
https://pubmed.ncbi.nlm.nih.gov/25208349Clinical outcomes of small-incision lenticule extraction and femtosecond laser-assisted wavefront-guided laser in situ keratomileusis.
David P Piñero, Miguel A Teus
https://pubmed.ncbi.nlm.nih.gov/27492109Comparison of visual and refractive outcomes following femtosecond laser- assisted lasik with smile in patients with myopia or myopic astigmatism.
Sri Ganesh, Rishika Gupta
https://pubmed.ncbi.nlm.nih.gov/25250415