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NCT Number: NCT05486546

Contoura With Phorcides Compared to Wavefront Optimized LASIK

Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

21 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vance Thompson Vison, Bozeman, Montana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Contoura with Phorcides

Procedure

Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine

WaveLight Wavefront Optimized

Device

Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Primary outcomes

  1. Post-Op UDVA

    Time frame: 3 months post-op

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

Secondary outcomes

  1. Post-OP BCVA

    Time frame: 3 months post-op

    Percent of participants with monocular and binocular BCVA of 20/16 or better

  2. Residual Refractive Error

    Time frame: 3 months post-op

    Residual astigmatism and residual SE

  3. Low Contrast Visual Acuity

    Time frame: 3 months post-op

    25% low contrast visual acuity post-op

  4. Pre-op and post-op visual acuity

    Time frame: 3 months post-op

    Percent of participants with post-op UDVA equal to or better than their pre-op CDVA

  5. Corrected Distance Visual Acuity

    Time frame: 3 months post-op

    Compare percent of participants with post-operative and pre-operative CDVA

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Terveen, MD

CONTACT

[email protected]

605-645-7999

Elise Meide, M.S.

CONTACT

[email protected]

605-645-0444

Sponsors and collaborators

Lead sponsor

Daniel Terveen

Other

Collaborators

  • Alcon Research

Registry information

Official study title

Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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