LASIK Surgery Comparison for Myopia and Astigmatism

This study is comparing two types of LASIK (laser-assisted in situ keratomileusis) eye surgery for people with myopia (nearsightedness) and astigmatism (blurry vision due to an imperfectly shaped eye). You might be able to join if you are between 21 and 38 years old and need LASIK. The study is testing if "Contoura with Phorcides" works better than "WaveLight Wavefront Optimized" LASIK. Researchers will look at how well you can see without glasses or contacts three months after surgery to see which method is more successful. The current status of this study is unclear, so it's not known if they are actively looking for participants.

Study design
This interventional study plans to enroll 120 participants to compare two different LASIK procedures.
What's involved
You would undergo LASIK eye surgery and need to complete a one-month post-operative visit.
Compensation
Not stated in the trial record.
Follow-up
Your vision will be measured three months after surgery to assess the primary outcome.

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NCT05486546

Contoura With Phorcides Compared to Wavefront Optimized LASIK

Recruiting
NAAges 21–38InterventionalTreatment
Daniel Terveen
~120 participants
Updated 2023-04-26 on ClinicalTrials.gov
What's tested:Contoura with PhorcidesWaveLight Wavefront Optimized

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-Op UDVA
Measured over 3 months post-op
Myopia
Astigmatism
4 sites across 4 states
Montana1
Nebraska1
North Dakota1
South Dakota1

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Eligibility criteria

Inclusion

Patients at least age 21 years of age undergoing LASIK eye surgery
Willing and able to comprehend informed consent and complete 1 month post-op visit
Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion
Candidates for Contoura with Phorcides (Myopic, astigmatism \<3.0D)
Both eyes targeted for plano
Pre-operative total corneal Pachymetry 490um or above
Stable refractive error \<0.50D change in preceding year
Good general and ocular health
Pre-operative exam completed within three months of surgery
SCL discontinued 3 days prior to pre-op exam and the procedure
Pachymetry above 490 with residual greater than 270um
Candidates who, as determined by the investigator, can safely undergo LASIK

Exclusion

Patients under 21 years of age
Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon
Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
Pachymetry below 490
Autoimmune or immunodeficiency diseases
Pregnant or nursing women
Patients with signs of inability to understand consent for study and procedure planned
Patients with history of previous ocular surgery
Patients with strabismus or amblyopia
Patients that have a BCDVA of 20/25 or worse in either eye
  • Post-Op UDVA3 months post-op

    Percent of participants with monocular UDVA of 20/16 or better