Patient Satisfaction With Contoura Vision Topography-Guided LASIK

Myopia Clinical Trial

Official title:

Patient Satisfaction With Contoura Vision Topography-Guided LASIK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903301
• Other study ID #: CV-LASIK
• Status: Completed
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Rush Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

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

Locations

Country	Name	City	State
United States	Rush Eye Associates	Amarillo	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Rush Eye Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Vision Satisfaction Index	Analog Score from Adapted from PROWL Survey	26 weeks
Secondary	Vision	Uncorrected Visual Acuity using ETDRS	26 weeks
Secondary	Objective Scatter Index	HD Analyzer	26 weeks
Secondary	Higher Order Corneal Aberrations	Galilei Topography	26 weeks