A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism

Official title

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.

Overview

This purpose of this study is to compare a new form of LASIK called Ray Tracing Guided LASIK to 3 other forms of corneal refractive surgery: 1. KLEx (KeratoLenticule Extraction) using the Zeiss Visumax 800 Laser, 2. WFO LASIK (Wavefront Optimized LASIK) using the Alcon EX500 Laser, and 3. Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser.

Detailed description

This is a prospective, randomized, simultaneous, contralateral eye study comparing visual outcomes for 4 different refractive technologies. This study will be conducted in 3 phases. Each phase will include at least 44 subjects undergoing refractive correction surgery for myopia or myopia with astigmatism. Each phase will compare Ray-Tracing LASIK to 1 of 3 other forms of corneal refractive surgery. The Phase 1 comparator will be KLEx (KeratoLenticule Extraction) using the Zeiss Visumax 800 Laser. The Phase 2 comparator will be WFO LASIK (Wavefront Optimized LASIK) using the Alcon EX500 Laser. The Phase 3 comparator will be Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. For each Phase, randomization will ensure 50% of Right Eyes will receive Ray-Tracing LASIK and 50% of Right Eyes will receive the other comparator procedure. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, 6-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, 6-month and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.

Interventions

• Device Ray-Tracing Guided LASIK
  A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
• Device Keratorefractive Lenticule Extraction (KLEx)
  A form of corneal refractive surgery utilizing a femtosecond laser to create a lens shaped lenticule of corneal tissue that is removed through a small corneal incision.
• Device WaveFront Optimized LASIK
  A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
• Device Topography Guided LASIK
  A form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea.

Primary outcome measures

• Uncorrected Visual Acuity [Time frame: 3, 6 and 12 month]

Secondary outcome measures (1)

• Predictability [Time frame: 3, 6, and 12 months]

Eligibility criteria

Inclusion criteria

• Age 22-50 at the time of consent
• Diagnosis of myopia or myopia with astigmatism with Preoperative manifest spherical equivalent refraction of ≥ -2.00 and ≤ -9.00 D (-2.00 D through -9.00 D)
• Preop Spherical component of ≥ -2.00 and ≤ -8.00 D (-2.00 D through -8.00 D)
• Refractive Cylinder of ≤ -3.00 D (0.00 through -3.00 D)
• BCVA of 20/20 or better in each eye (83 or more letters on the ETDRS Chart)
• Subjects must have a stable refraction which is defined as a change in spherical equivalent no greater than 0.50 D comparing the screening visit manifest refraction to a previous refraction, spectacle Rx, or contact lens Rx, 12 months or older.
• Subjects who are contact lens wearers must discontinue the use of soft lenses (spherical or toric) for at least 5 days and hard or gas-permeable lenses for at least 4 weeks prior to the preoperative screening evaluation. Hard or gas-permeable lens wearers must not return to contact lens use before surgery. Soft lens wearers may resume contact lens wear after all preoperative testing is completed, but must discontinue lens use at least 5 days before surgery.
• Acceptable preoperative tomography and examination results for refractive procedures as determined by the Principal Investigator.
• Surgical plan includes treatment target for emmetropia in both eyes, and no monovision.
• Subject is capable and willing to use postoperative medications as prescribed.
• Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.
• Subject is willing and able to return for all postoperative examinations.

Exclusion criteria

• Clinically significant dry eye on clinical examination, as determined by the investigator
• Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography
• History of corneal dystrophies or guttata
• History of herpetic keratitis or active disease
• History of prior refractive surgery
• History of glaucoma or glaucoma suspect
• History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.
• Females who are pregnant, breastfeeding, or intend to become pregnant any time during the study as determined by verbal inquiry.
• The Principal Investigator has determined the subject not to be a good candidate for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Hoopes Moshirfar Research Center — Draper

Publications

• Khoramnia R, Lohmann CP, Wuellner C, Kobuch KA, Donitzky C, Winkler von Mohrenfels C. Effect of 3 excimer laser ablation frequencies (200 Hz, 500 Hz, 1000 Hz) on the cornea using a 1000 Hz scanning-spot excimer laser. J Cataract Refract Surg. 2010 Aug;36(8):1385-91. doi: 10.1016/j.jcrs.2010.01.033. PMID 20656164
• Winkler von Mohrenfels C, Khoramnia R, Lohmann CP. Comparison of different excimer laser ablation frequencies (50, 200, and 500 Hz). Graefes Arch Clin Exp Ophthalmol. 2009 Nov;247(11):1539-45. doi: 10.1007/s00417-009-1102-x. Epub 2009 Jul 14. PMID 19597838
• Meidani A, Tzavara C. Comparison of efficacy, safety, and predictability of laser in situ keratomileusis using two laser suites. Clin Ophthalmol. 2016 Aug 24;10:1639-46. doi: 10.2147/OPTH.S110626. eCollection 2016. PMID 27601880
• Mrochen M, Donitzky C, Wullner C, Loffler J. Wavefront-optimized ablation profiles: theoretical background. J Cataract Refract Surg. 2004 Apr;30(4):775-85. doi: 10.1016/j.jcrs.2004.01.026. PMID 15093638
• Mrochen M, Seiler T. Influence of corneal curvature on calculation of ablation patterns used in photorefractive laser surgery. J Refract Surg. 2001 Sep-Oct;17(5):S584-7. doi: 10.3928/1081-597X-20010901-15. PMID 11583235
• Ganesh S, Brar S, Swamy DT. Comparison of Clinical Outcomes and Patient Satisfaction Following SMILE Performed With the VisuMax 800 in One Eye and VisuMax 500 in the Contralateral Eye. J Refract Surg. 2025 Jan;41(1):e14-e21. doi: 10.3928/1081597X-20241113-02. Epub 2025 Jan 1. PMID 39783817
• Reinstein DZ, Archer TJ, Potter JG, Gupta R, Wiltfang R. Refractive and Visual Outcomes of SMILE for Compound Myopic Astigmatism With the VISUMAX 800. J Refract Surg. 2023 May;39(5):294-301. doi: 10.3928/1081597X-20230301-02. Epub 2023 May 1. PMID 37162399
• Teus MA, Garcia-Gonzalez M. Comparison of the visual results after small incision lenticule extraction and femtosecond laser-assisted LASIK for myopia. J Refract Surg. 2014 Sep;30(9):582. doi: 10.3928/1081597X-20140819-01. No abstract available. PMID 25208349

Identifiers

NCT: NCT07201298 · HMRC-WLP-VWC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗