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

ConditionsMyopiaAstigmatism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-50
SponsorHoopes Vision

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ray-Tracing Guided LASIK

    Device

    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 LASIK

    Device

    A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.

  • 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.

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OSActive comparator 2 interventions
Group B: ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in ODActive comparator 2 interventions
Group C: ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OSActive comparator 2 interventions
Group D: ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in ODActive comparator 2 interventions
Group E: ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OSActive comparator 2 interventions
Group F: ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in ODActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
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.

Time frame
3, 6, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoopes Vision

Lead sponsor

Source ClinicalTrials.gov
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