Contoura With Phorcides Compared to Wavefront Optimized LASIK

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

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

Study Overview

• Status: Recruiting
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Procedure: Contoura with Phorcides; Device: WaveLight Wavefront Optimized

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Terveen, MD; Phone Number: 605-645-7999; Email: daniel.terveen@vancethompsonvision.com
• Study Contact Backup: Name: Elise Meide, M.S.; Phone Number: 605-645-0444; Email: elise.reid@coyotes.usd.edu

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 57105
      • Recruiting
      • Vance Thompson Vison
      • Contact: Keeley Boever; Phone Number: 402-740-9420; Email: keeley.boever@vancethompsonvision.com
  • Nebraska
    • Omaha, Nebraska, United States, 57105
      • Recruiting
      • Vance Thompson Vision
      • Contact: Keeley Boever; Phone Number: 402-740-9420; Email: keeley.boever@vancethompsonvision.com
  • North Dakota
    • Fargo, North Dakota, United States, 57105
      • Recruiting
      • Vance Thompson Vision
      • Contact: Keeley Boever; Phone Number: 402-740-9420; Email: keeley.boever@vancethompsonvision.com
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 38 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study: Phorcides; Contoura with Phorcides used for surgical planning of LASIK procedure	Procedure: Contoura with Phorcides; Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine
Active Comparator: Control: Wavefront Optimized; WaveLight Wavefront Optimized used for surgical planning of LASIK procedure	Device: WaveLight Wavefront Optimized; Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Op UDVA	Percent of participants with monocular UDVA of 20/16 or better	3 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-OP BCVA	Percent of participants with monocular and binocular BCVA of 20/16 or better	3 months post-op
Residual Refractive Error	Residual astigmatism and residual SE	3 months post-op
Low Contrast Visual Acuity	25% low contrast visual acuity post-op	3 months post-op
Pre-op and post-op visual acuity	Percent of participants with post-op UDVA equal to or better than their pre-op CDVA	3 months post-op
Corrected Distance Visual Acuity	Compare percent of participants with post-operative and pre-operative CDVA	3 months post-op

Collaborators and Investigators

• Sponsor: Daniel Terveen
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: LASIK; Visual acuity; Contrast sensitivity; Refractive outcome; Wavefront Optimized; Topography-guided
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: AMPLIO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes