NCT05486546

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

August 1, 2022

Last Update Submit

April 24, 2023

Conditions

MyopiaAstigmatism

Keywords

Visual acuityRefractive outcomeLASIKContrast sensitivityWavefront OptimizedTopography-guided

Outcome Measures

Primary Outcomes (1)

  • Post-Op UDVA

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

    3 months post-op

Secondary Outcomes (5)

  • Post-OP BCVA

    3 months post-op

  • Residual Refractive Error

    3 months post-op

  • Low Contrast Visual Acuity

    3 months post-op

  • Pre-op and post-op visual acuity

    3 months post-op

  • Corrected Distance Visual Acuity

    3 months post-op

Study Arms (2)

Study: Phorcides

EXPERIMENTAL

Contoura with Phorcides used for surgical planning of LASIK procedure

Procedure: Contoura with Phorcides

Control: Wavefront Optimized

ACTIVE COMPARATOR

WaveLight Wavefront Optimized used for surgical planning of LASIK procedure

Device: WaveLight Wavefront Optimized

Interventions

Contoura with PhorcidesPROCEDURE

Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine

Study: Phorcides
WaveLight Wavefront OptimizedDEVICE

Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Control: Wavefront Optimized

Eligibility Criteria

Age21 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vance Thompson Vison

Bozeman, Montana, 57105, United States

RECRUITING

Vance Thompson Vision

Omaha, Nebraska, 57105, United States

RECRUITING

Vance Thompson Vision

Fargo, North Dakota, 57105, United States

RECRUITING

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

RECRUITING

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Daniel Terveen, MD

CONTACT

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

Elise Meide, M.S.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

August 15, 2022

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(4)