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Contoura With Phorcides Compared to Wavefront Optimized LASIK

Primary Purpose

Myopia, Astigmatism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contoura with Phorcides
WaveLight Wavefront Optimized
Sponsored by
Daniel Terveen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Visual acuity, Refractive outcome, LASIK, Contrast sensitivity, Wavefront Optimized, Topography-guided

Eligibility Criteria

21 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vance Thompson VisonRecruiting
  • Vance Thompson VisionRecruiting
  • Vance Thompson VisionRecruiting
  • Vance Thompson VisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study: Phorcides

Control: Wavefront Optimized

Arm Description

Contoura with Phorcides used for surgical planning of LASIK procedure

WaveLight Wavefront Optimized used for surgical planning of LASIK procedure

Outcomes

Primary Outcome Measures

Post-Op UDVA
Percent of participants with monocular UDVA of 20/16 or better

Secondary Outcome Measures

Post-OP BCVA
Percent of participants with monocular and binocular BCVA of 20/16 or better
Residual Refractive Error
Residual astigmatism and residual SE
Low Contrast Visual Acuity
25% low contrast visual acuity 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
Corrected Distance Visual Acuity
Compare percent of participants with post-operative and pre-operative CDVA

Full Information

First Posted
August 1, 2022
Last Updated
April 24, 2023
Sponsor
Daniel Terveen
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05486546
Brief Title
Contoura With Phorcides Compared to Wavefront Optimized LASIK
Official Title
Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Terveen
Collaborators
Alcon Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
Keywords
Visual acuity, Refractive outcome, LASIK, Contrast sensitivity, Wavefront Optimized, Topography-guided

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study: Phorcides
Arm Type
Experimental
Arm Description
Contoura with Phorcides used for surgical planning of LASIK procedure
Arm Title
Control: Wavefront Optimized
Arm Type
Active Comparator
Arm Description
WaveLight Wavefront Optimized used for surgical planning of LASIK procedure
Intervention Type
Procedure
Intervention Name(s)
Contoura with Phorcides
Intervention Description
Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine
Intervention Type
Device
Intervention Name(s)
WaveLight Wavefront Optimized
Intervention Description
Participants that undergo LASIK surgery using WaveLight Wavefront Optimized
Primary Outcome Measure Information:
Title
Post-Op UDVA
Description
Percent of participants with monocular UDVA of 20/16 or better
Time Frame
3 months post-op
Secondary Outcome Measure Information:
Title
Post-OP BCVA
Description
Percent of participants with monocular and binocular BCVA of 20/16 or better
Time Frame
3 months post-op
Title
Residual Refractive Error
Description
Residual astigmatism and residual SE
Time Frame
3 months post-op
Title
Low Contrast Visual Acuity
Description
25% low contrast visual acuity post-op
Time Frame
3 months post-op
Title
Pre-op and post-op visual acuity
Description
Percent of participants with post-op UDVA equal to or better than their pre-op CDVA
Time Frame
3 months post-op
Title
Corrected Distance Visual Acuity
Description
Compare percent of participants with post-operative and pre-operative CDVA
Time Frame
3 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Terveen, MD
Phone
605-645-7999
Email
daniel.terveen@vancethompsonvision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Meide, M.S.
Phone
605-645-0444
Email
elise.reid@coyotes.usd.edu
Facility Information:
Facility Name
Vance Thompson Vison
City
Bozeman
State/Province
Montana
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keeley Boever
Phone
402-740-9420
Email
keeley.boever@vancethompsonvision.com
Facility Name
Vance Thompson Vision
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keeley Boever
Phone
402-740-9420
Email
keeley.boever@vancethompsonvision.com
Facility Name
Vance Thompson Vision
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keeley Boever
Phone
402-740-9420
Email
keeley.boever@vancethompsonvision.com
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keeley Puls
Phone
605-371-7075
Email
keeley.puls@vancethompsonvision.com

12. IPD Sharing Statement

Learn more about this trial

Contoura With Phorcides Compared to Wavefront Optimized LASIK

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