NCT04903301

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.4 years

First QC Date

May 21, 2021

Last Update Submit

November 15, 2023

Conditions

MyopiaAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Global Vision Satisfaction Index

    Analog Score from Adapted from PROWL Survey

    26 weeks

Secondary Outcomes (3)

  • Vision

    26 weeks

  • Objective Scatter Index

    26 weeks

  • Higher Order Corneal Aberrations

    26 weeks

Study Arms (1)

Study Group

EXPERIMENTAL

Contoura Vision LASIK using Phorcides Analytic Software

Procedure: Contoura Vision LASIK

Interventions

Contoura Vision LASIKPROCEDURE

Topography-Guided LASIK using Phorcides Analytic Software

Study Group

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush Eye Associates

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2021

First Posted

May 26, 2021

Study Start

May 21, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

US(1)