Patient Satisfaction With Contoura Vision Topography-Guided LASIK

Sponsor
Rush Eye Associates (Other)
Overall Status
Recruiting
CT.gov ID
NCT04903301
Collaborator
(none)
50
1
1
24
2.1

Study Details

Study Description

Brief Summary

To evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Contoura Vision LASIK
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Patient Satisfaction With Contoura Vision Topography-Guided LASIK
Actual Study Start Date :
May 21, 2021
Anticipated Primary Completion Date :
May 21, 2023
Anticipated Study Completion Date :
May 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group

Contoura Vision LASIK using Phorcides Analytic Software

Procedure: Contoura Vision LASIK
Topography-Guided LASIK using Phorcides Analytic Software

Outcome Measures

Primary Outcome Measures

  1. Global Vision Satisfaction Index [26 weeks]

    Analog Score from Adapted from PROWL Survey

Secondary Outcome Measures

  1. Vision [26 weeks]

    Uncorrected Visual Acuity using ETDRS

  2. Objective Scatter Index [26 weeks]

    HD Analyzer

  3. Higher Order Corneal Aberrations [26 weeks]

    Galilei Topography

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush Eye Associates Amarillo Texas United States 79106

Sponsors and Collaborators

  • Rush Eye Associates

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sloan W. Rush, MD, Principal Investigator, Rush Eye Associates
ClinicalTrials.gov Identifier:
NCT04903301
Other Study ID Numbers:
  • CV-LASIK
First Posted:
May 26, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021