Recruiting

Contoura vs. Wavefront Optimized

Sponsor:

Daniel Terveen

Code:

NCT05486546

Conditions

Myopia

Astigmatism

Eligibility Criteria

Sex: All

Age: 21 - 38

Healthy Volunteers: Not accepted

Interventions

Contoura with Phorcides

WaveLight Wavefront Optimized

Study Details

Brief summary:

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

Conditions

Myopia

Astigmatism

Study ID

NCT05486546

Start date

Aug 15, 2022

Status verified date

Apr, 2023

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Sep 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 38

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study: Phorcides

Contoura with Phorcides used for surgical planning of LASIK procedure

active comparator: Control: Wavefront Optimized

WaveLight Wavefront Optimized used for surgical planning of LASIK procedure

Interventions

Contoura with Phorcides

Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine

WaveLight Wavefront Optimized

Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Primary outcome measure

  • Post-Op UDVA [ Time Frame: 3 months post-op ]

Central Contacts and Locations

Central contacts

Daniel Terveen, MD

605-645-7999daniel.terveen@vancethompsonvision.com

Elise Meide, M.S.

605-645-0444elise.reid@coyotes.usd.edu

Locations

Vance Thompson Vison

Recruiting

Bozeman, Montana, United States, 57105

Contacts

Keeley Boever

402-740-9420keeley.boever@vancethompsonvision.com

Vance Thompson Vision

Recruiting

Omaha, Nebraska, United States, 57105

Contacts

Keeley Boever

402-740-9420keeley.boever@vancethompsonvision.com

Vance Thompson Vision

Recruiting

Fargo, North Dakota, United States, 57105

Contacts

Keeley Boever

402-740-9420keeley.boever@vancethompsonvision.com

Vance Thompson Vision

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Keeley Puls

605-371-7075keeley.puls@vancethompsonvision.com

More Information

Sponsor

Daniel Terveen

Last update posted

Apr 26, 2023

Last verified

Apr, 2023

Keywords

  • Visual acuity
  • Refractive outcome
  • LASIK
  • Contrast sensitivity
  • Wavefront Optimized
  • Topography-guided

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Daniel Terveen on 2023-04-26.