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OpenTrials
Completed

NCT Number: NCT04903301

Patient Satisfaction With Contoura Vision Topography-Guided LASIK

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

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Key information

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush Eye Associates

Amarillo, Texas, 79106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contoura Vision LASIK

Procedure

Topography-Guided LASIK using Phorcides Analytic Software

Primary outcomes

  1. Global Vision Satisfaction Index

    Time frame: 26 weeks

    Analog Score from Adapted from PROWL Survey

Secondary outcomes

  1. Vision

    Time frame: 26 weeks

    Uncorrected Visual Acuity using ETDRS

  2. Objective Scatter Index

    Time frame: 26 weeks

    HD Analyzer

  3. Higher Order Corneal Aberrations

    Time frame: 26 weeks

    Galilei Topography

Sponsors and collaborators

Lead sponsor

Rush Eye Associates

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 26, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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