MyopiaNCT07201298
A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism
A study testing Ray-Tracing Guided LASIK, Keratorefractive Lenticule Extraction (KLEx) and WaveFront Optimized LASIK in people with Myopia and Astigmatism, run by Hoopes Vision at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Ray-Tracing Guided LASIK, Keratorefractive Lenticule Extraction (KLEx) and WaveFront Optimized LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hoopes Moshirfar Research Center
Draper, Utah, 84020
Steven H Linn, OD, 801-988-7342, slinn@hoopesvision.com
Shealynn Petersen, BS, 801-988-7342, sheapetersen@hoopesvision.com
About this study
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.
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.
Read the 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.
- Conditions
- Myopia, Astigmatism
- Being tested
- Ray-Tracing Guided LASIK, Keratorefractive Lenticule Extraction (KLEx), WaveFront Optimized LASIK, Topography Guided LASIK
- Keywords
- refractive surgery, myopia, astigmatism, excimer laser, femtosecond laser, Ray Tracing, Lenticule, SMILE, KLEx, Contoura, Topography Guided LASIK, Wavefront Optimized
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ray-Tracing Guided LASIKDevice
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
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.
WaveFront Optimized LASIKDevice
A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
Topography Guided LASIKDevice
A form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: Device: Ray-Tracing Guided LASIK; Device: Topography Guided LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3, 6 and 12 month
Secondary outcomes (1)
Predictability
Percentage of eyes that acheive MRSE within +/- 0.5 diopters and +/- 1.00 diopters of intended correction at post-operative visits 3, 6, and 12-months.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoopes Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Majid Moshirfar, MD, Principal investigator, Hoopes Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201298
- Sponsor's protocol ID
- HMRC-WLP-VWC
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 20656164Winkler 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.
PubMed 19597838Meidani 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.
PubMed 27601880Mrochen 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.
PubMed 15093638Mrochen 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.
PubMed 11583235Ganesh 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.
PubMed 39783817Reinstein 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.
PubMed 37162399Teus 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.
PubMed 25208349Pinero 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.
PubMed 27492109Ganesh 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.
PubMed 25250415Shah 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.
PubMed 21183108Sekundo 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.
PubMed 20601657Blum 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.
PubMed 26746577Reinstein 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.
PubMed 26605350Lee 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.
PubMed 26058022
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07201298
- Acronym / sponsor ID
- HMRC-WLP-VWC
- Conditions
- Myopia, Astigmatism
- Keywords
- refractive surgery, myopia, astigmatism, excimer laser, femtosecond laser, Ray Tracing, Lenticule, SMILE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hoopes VisionUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS | Active comparator | Device: Ray-Tracing Guided LASIK, Device: Keratorefractive Lenticule Extraction (KLEx)Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Keratorefractive Lenticule Extraction in the LEFT EYE |
| ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD | Active comparator | Device: Ray-Tracing Guided LASIK, Device: Keratorefractive Lenticule Extraction (KLEx)Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Keratorefractive Lenticule Extraction in the RIGHT EYE |
| ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS | Active comparator | Device: Ray-Tracing Guided LASIK, Device: WaveFront Optimized LASIKSubjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Wavefront Optimized LASIK in the LEFT EYE. |
| ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD | Active comparator | Device: Ray-Tracing Guided LASIK, Device: WaveFront Optimized LASIKSubjects receive Ray Tracing Guided LASIK in the LEFT EYE and Wavefront Optimized LASIK in the RIGHT EYE |
| ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS | Active comparator | Device: Ray-Tracing Guided LASIK, Device: Topography Guided LASIKSubjects receive Ray Tracing Guided in the RIGHT EYE and Topography Guided LASIK in the LEFT EYE |
| ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD | Active comparator | Device: Ray-Tracing Guided LASIK, Device: Topography Guided LASIKSubjects receive Ray Tracing Guided LASIK in the LEFT EYE and Topography Guided LASIK in the RIGHT EYE |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ray-Tracing Guided LASIKA form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea. | Device | 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)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 | 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 LASIKA form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration. | Device | 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 LASIKA form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea. | Device | 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 |
Primary outcome
Uncorrected Visual Acuity
Time frame: 3, 6 and 12 month
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
1 secondary outcome
Predictability
Time frame: 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 20656164Khoramnia 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.
- Background: PubMed 19597838Winkler 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.
- Background: PubMed 27601880Meidani 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.
- Background: PubMed 15093638Mrochen 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.
- Background: PubMed 11583235Mrochen 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.
- Background: PubMed 39783817Ganesh 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.
- Background: PubMed 37162399Reinstein 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.
- Background: PubMed 25208349Teus 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.
- Background: PubMed 27492109Pinero 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.
- Background: PubMed 25250415Ganesh 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.
- Background: PubMed 21183108Shah 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.
- Background: PubMed 20601657Sekundo 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.
- Individual participant dataSharing planned: Undecided
Related trials for Myopia
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Majid Moshirfar, MD principal investigator
Hoopes Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ray-Tracing Guided LASIK, Keratorefractive Lenticule Extraction (KLEx) and WaveFront Optimized LASIK in people with Myopia and Astigmatism, run by Hoopes Vision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven H Linn, OD (801-988-7342, slinn@hoopesvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual Acuity (time frame: 3, 6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07201298, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.