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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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. |
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| 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 |
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| ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ray-Tracing Guided LASIK | Device | A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven H Linn, OD | Contact | 801-988-7342 | slinn@hoopesvision.com | |
| Shealynn Petersen, BS | Contact | 801-988-7342 | sheapetersen@hoopesvision.com |
| Name | Affiliation | Role |
|---|---|---|
| Majid Moshirfar, MD | Hoopes Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoopes Moshirfar Research Center | Recruiting | Draper | Utah | 84020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20656164 | Background | 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. | |
| 19597838 | Background |
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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.
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| Active Comparator |
Subjects 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 | Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Topography Guided LASIK in the RIGHT EYE |
|
| 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 LASIK | Device | A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration. |
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| 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. |
|
| 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. |
| 27601880 | 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. |
| 15093638 | 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. |
| 11583235 | 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. |
| 39783817 | 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. |
| 37162399 | 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. |
| 25208349 | 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. |
| 27492109 | 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. |
| 25250415 | 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. |
| 21183108 | 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. |
| 20601657 | 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. |
| 26746577 | 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. |
| 26605350 | 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. |
| 26058022 | 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. |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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