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

Hoopes Vision

Status: Enrolling

Conditions: Myopia; Astigmatism

Treatments: Device: Ray-Tracing Guided LASIK; Device: Keratorefractive Lenticule Extraction (KLEx); Device: Topography Guided LASIK; Device: WaveFront Optimized LASIK

Study type: Interventional

Funder types: Other

Identifiers

NCT07201298

HMRC-WLP-VWC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

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

Active Comparator group

Description:

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

Treatment:

Device: Keratorefractive Lenticule Extraction (KLEx)

Device: Ray-Tracing Guided LASIK

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

Active Comparator group

Description:

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

Treatment:

Device: Keratorefractive Lenticule Extraction (KLEx)

Device: Ray-Tracing Guided LASIK

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

Active Comparator group

Description:

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

Treatment:

Device: WaveFront Optimized LASIK

Device: Ray-Tracing Guided LASIK

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

Active Comparator group

Description:

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

Treatment:

Device: WaveFront Optimized LASIK

Device: Ray-Tracing Guided LASIK

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

Active Comparator group

Description:

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

Treatment:

Device: Topography Guided LASIK

Device: Ray-Tracing Guided LASIK

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

Active Comparator group

Description:

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

Treatment:

Device: Topography Guided LASIK

Device: Ray-Tracing Guided LASIK