Astigmatism, Myopia
Conditions
Keywords
refractive surgery, myopia, astigmatism, excimer laser, femtosecond laser, Ray Tracing, Lenticule, SMILE, KLEx, Contoura, Topography Guided LASIK, Wavefront Optimized
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.
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
DEVICERay-Tracing Guided LASIK
A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.
DEVICEKeratorefractive 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.
A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.
DEVICETopography Guided LASIK
A form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea.
Sponsors
Hoopes Vision
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
22 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 22-50 at the time of consent 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
1. Clinically significant dry eye on clinical examination, as determined by the investigator 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictability | 3, 6, and 12 months | 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. |
Countries
United States
Contacts
Primary ContactSteven H Linn, OD
Backup ContactShealynn Petersen, BS
Outcome results
None listed