Back to resultsPatient Satisfaction With Contoura Vision Topography-Guided LASIK
Primary Purpose
Myopia, Astigmatism
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Contoura Vision LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Eligibility criteria: The study enrollment will include all willing patients with: pre-operative BCVA 20/20 for each eye individually, myopic refractive error up to -8.00 diopters, refractive astigmatism that ranges from 0 to 3 diopters, maximum spherical equivalent of -9.00 diopters, the designated age requirements, and only patients that have signed the informed consent document.
Exclusion criteria: Patients are excluded that are not willing to participate in a research trial, are unable to cooperate well enough to safely perform the procedure, fail to meet inclusion criteria, have ocular disease (including but not limited to keratoconus, macular degeneration, glaucoma, corneal dystrophy, dry eye syndrome and corneal scarring), and patients that have had previous ocular surgery. Any patients with known allergies to the post-operative medications or preservatives in the medications will also be excluded.
Sites / Locations
- Rush Eye AssociatesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Contoura Vision LASIK using Phorcides Analytic Software
Outcomes
Primary Outcome Measures
Global Vision Satisfaction Index
Analog Score from Adapted from PROWL Survey
Secondary Outcome Measures
Vision
Uncorrected Visual Acuity using ETDRS
Objective Scatter Index
HD Analyzer
Higher Order Corneal Aberrations
Galilei Topography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04903301
Brief Title
Patient Satisfaction With Contoura Vision Topography-Guided LASIK
Official Title
Patient Satisfaction With Contoura Vision Topography-Guided LASIK
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 21, 2023 (Anticipated)
Study Completion Date
May 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush Eye Associates
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.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Contoura Vision LASIK using Phorcides Analytic Software
Intervention Type
Procedure
Intervention Name(s)
Contoura Vision LASIK
Intervention Description
Topography-Guided LASIK using Phorcides Analytic Software
Primary Outcome Measure Information:
Title
Global Vision Satisfaction Index
Description
Analog Score from Adapted from PROWL Survey
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Vision
Description
Uncorrected Visual Acuity using ETDRS
Time Frame
26 weeks
Title
Objective Scatter Index
Description
HD Analyzer
Time Frame
26 weeks
Title
Higher Order Corneal Aberrations
Description
Galilei Topography
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility criteria: The study enrollment will include all willing patients with: pre-operative BCVA 20/20 for each eye individually, myopic refractive error up to -8.00 diopters, refractive astigmatism that ranges from 0 to 3 diopters, maximum spherical equivalent of -9.00 diopters, the designated age requirements, and only patients that have signed the informed consent document.
Exclusion criteria: Patients are excluded that are not willing to participate in a research trial, are unable to cooperate well enough to safely perform the procedure, fail to meet inclusion criteria, have ocular disease (including but not limited to keratoconus, macular degeneration, glaucoma, corneal dystrophy, dry eye syndrome and corneal scarring), and patients that have had previous ocular surgery. Any patients with known allergies to the post-operative medications or preservatives in the medications will also be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sloan Rush, MD
Phone
806-353-0125
Email
sunday.fowler@paneye.com
Facility Information:
Facility Name
Rush Eye Associates
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunday Fowler
Phone
806-353-0125
First Name & Middle Initial & Last Name & Degree
Sloan W Rush, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Patient Satisfaction With Contoura Vision Topography-Guided LASIK
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