A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
NCT ID: NCT07201298
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2025-09-30
2029-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
NCT02987660
Contralateral Comparison of Three Excimer Laser Systems in Performing LASIK
NCT00821236
Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery
NCT07078799
SMILE vs. LASIK Using Contoura With Phorcides
NCT05844397
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
NCT05611294
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS
Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Keratorefractive Lenticule Extraction in the LEFT EYE
Ray-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
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.
ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD
Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Keratorefractive Lenticule Extraction in the RIGHT EYE
Ray-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
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.
ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS
Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Wavefront Optimized LASIK in the LEFT EYE.
Ray-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
WaveFront Optimized LASIK
A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD
Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Wavefront Optimized LASIK in the RIGHT EYE
Ray-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
WaveFront Optimized LASIK
A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS
Subjects receive Ray Tracing Guided in the RIGHT EYE and Topography Guided LASIK in the LEFT EYE
Ray-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
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.
ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD
Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Topography Guided LASIK in the RIGHT EYE
Ray-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ray-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
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.
WaveFront Optimized LASIK
A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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)
3. Preop Spherical component of ≥ -2.00 and ≤ -8.00 D (-2.00 D through -8.00 D)
4. Refractive Cylinder of ≤ -3.00 D (0.00 through -3.00 D)
5. BCVA of 20/20 or better in each eye (83 or more letters on the ETDRS Chart)
6. 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.
7. 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.
8. Acceptable preoperative tomography and examination results for refractive procedures as determined by the Principal Investigator.
9. Surgical plan includes treatment target for emmetropia in both eyes, and no monovision.
10. Subject is capable and willing to use postoperative medications as prescribed.
11. Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.
12. Subject is willing and able to return for all postoperative examinations.
Exclusion Criteria
2. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography
3. History of corneal dystrophies or guttata
4. History of herpetic keratitis or active disease
5. History of prior refractive surgery
6. History of glaucoma or glaucoma suspect
7. History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.
8. Females who are pregnant, breastfeeding, or intend to become pregnant any time during the study as determined by verbal inquiry.
9. The Principal Investigator has determined the subject not to be a good candidate for the study.
22 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoopes Vision
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Majid Moshirfar, MD
Role: PRINCIPAL_INVESTIGATOR
Hoopes Vision
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hoopes Moshirfar Research Center
Draper, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HMRC-WLP-VWC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.