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

NCT07201298 | Recruiting FDA Device

• 1 other identifier: HMRC-WLP-VWC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Astigmatism

Keywords

refractive surgery; myopia; astigmatism; excimer laser; femtosecond laser; Ray Tracing; Lenticule; SMILE; KLEx; Contoura; Topography Guided LASIK; Wavefront Optimized

Outcome Measures

Primary Outcomes (1)

• Uncorrected Visual Acuity

  Percentage of eyes acheiving uncorrected visual acuity of 20/40, 20/25, 20/20, 20/16, 20/12.5, and 20/10 at post-operative month 3, 6 and 12

  3, 6 and 12 month

Secondary Outcomes (1)

• Predictability

  3, 6, and 12 months

Study Arms (6)

ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS

ACTIVE COMPARATOR

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

Device: Ray-Tracing Guided LASIK; Device: Keratorefractive Lenticule Extraction (KLEx)

ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD

ACTIVE COMPARATOR

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

Device: Ray-Tracing Guided LASIK; Device: Keratorefractive Lenticule Extraction (KLEx)

ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS

ACTIVE COMPARATOR

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

Device: Ray-Tracing Guided LASIK; Device: WaveFront Optimized LASIK

ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD

ACTIVE COMPARATOR

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

Device: Ray-Tracing Guided LASIK; Device: WaveFront Optimized LASIK

ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS

ACTIVE COMPARATOR

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

Device: Ray-Tracing Guided LASIK; Device: Topography Guided LASIK

ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD

ACTIVE COMPARATOR

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

Device: Ray-Tracing Guided LASIK; Device: Topography Guided LASIK

Interventions

Ray-Tracing Guided LASIK DEVICE

A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.

ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS; ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD; ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS; ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD; ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS; ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD

Keratorefractive Lenticule Extraction (KLEx) DEVICE

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.

ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS; ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD

WaveFront Optimized LASIK DEVICE

A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.

ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS; ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD

Topography Guided LASIK DEVICE

A form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea.

ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS; ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoopes Vision: lead

Study Sites (1)

Hoopes Moshirfar Research Center

Draper, Utah, 84020, United States

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Pinero DP, Teus MA. Clinical outcomes of small-incision lenticule extraction and femtosecond laser-assisted wavefront-guided laser in situ keratomileusis. J Cataract Refract Surg. 2016 Jul;42(7):1078-93. doi: 10.1016/j.jcrs.2016.05.004.

  PMID: 27492109 BACKGROUND

• Ganesh S, Gupta R. Comparison of visual and refractive outcomes following femtosecond laser- assisted lasik with smile in patients with myopia or myopic astigmatism. J Refract Surg. 2014 Sep;30(9):590-6. doi: 10.3928/1081597X-20140814-02.

  PMID: 25250415 BACKGROUND

• Shah R, Shah S, Sengupta S. Results of small incision lenticule extraction: All-in-one femtosecond laser refractive surgery. J Cataract Refract Surg. 2011 Jan;37(1):127-37. doi: 10.1016/j.jcrs.2010.07.033.

  PMID: 21183108 BACKGROUND

• Sekundo W, Kunert KS, Blum M. Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study. Br J Ophthalmol. 2011 Mar;95(3):335-9. doi: 10.1136/bjo.2009.174284. Epub 2010 Jul 3.

  PMID: 20601657 BACKGROUND

• Blum M, Taubig K, Gruhn C, Sekundo W, Kunert KS. Five-year results of Small Incision Lenticule Extraction (ReLEx SMILE). Br J Ophthalmol. 2016 Sep;100(9):1192-5. doi: 10.1136/bjophthalmol-2015-306822. Epub 2016 Jan 8.

  PMID: 26746577 BACKGROUND

• Reinstein DZ, Archer TJ, Gobbe M. Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes. Eye Vis (Lond). 2014 Oct 16;1:3. doi: 10.1186/s40662-014-0003-1. eCollection 2014.

  PMID: 26605350 BACKGROUND

• Lee JK, Chuck RS, Park CY. Femtosecond laser refractive surgery: small-incision lenticule extraction vs. femtosecond laser-assisted LASIK. Curr Opin Ophthalmol. 2015 Jul;26(4):260-4. doi: 10.1097/ICU.0000000000000158.

  PMID: 26058022 BACKGROUND

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Majid Moshirfar, MD

  Hoopes Vision

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven H Linn, OD

CONTACT

801-988-7342; slinn@hoopesvision.com

Shealynn Petersen, BS

CONTACT

801-988-7342; sheapetersen@hoopesvision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A= Ray-Tracing Guided LASIK (RTGL) B= Keratorefractive Lenticule Extraction (KLEx) C=WaveFront Optimized LASIK (WFOL) D= Topography Guided LASIK (TGL) This is a contralateral eye study with 3 different phases: Phase 1 has 2 Arms: Arm 1 consists of 22 subjects who have RTGL in the Right Eye and KLEx in the Left Eye, Arm 2 consists of 22 subjects who have KLEx in the Right Eye and RTGL in the Left Eye. Phase 2 has 2 Arms: Arm 1 consists of 22 subjects who have RTGL in the Right Eye and WFOL in the Left Eye, Arm 2 consists of 22 subjects who have WFOL in the Right Eye and RTGL in the Left Eye. Phase 3 has 2 Arms: Arm 1 consists of 22 subjects who have RTGL in the Right Eye and TGL in the Left Eye, Arm 2 consists of 22 subjects who have TGL in the Right Eye and RTGL in the Left Eye.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)