NCT05848817

Brief Summary

The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura 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 all trials

Timeline
Completed

Started May 2023

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

April 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

April 28, 2023

Results QC Date

June 30, 2025

Last Update Submit

July 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Subject Satisfaction

    Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.

    3 Months Postoperative

Secondary Outcomes (1)

  • Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D

    3 Months Postoperative

Other Outcomes (2)

  • PROWL Questionnaire

    3 Months Postoperative

  • OSDI Score

    3 Months Postoperative

Study Arms (1)

Contoura LASIK

Subjects receiving Phorcides Planned Contoura LASIK.

Device: Contoura LASIK

Interventions

Subjects receiving Phorcides Planned Contoura LASIK

Contoura LASIK

Eligibility Criteria

Age21 Years - 39 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects 21 to 39 years of who are appropriate candidates for laser refractive surgery.

You may not qualify if:

  • Subjects with history of previous ocular surgery.
  • Subjects with topographic evidence of keratoconus, or ectasia.
  • Subjects with autoimmune diseases.
  • Subjects who are pregnant or nursing.
  • Systemic disease likely to affect wound healing, such as diabetes and severe atopy.
  • Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery.
  • The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
  • Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mann Eye Institute

Houston, Texas, 76134-2099, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Phillip Brunson
Organization
Mann Eye Institute

Study Officials

  • Phillip Brunson, OD

    Mann Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 8, 2023

Study Start

May 19, 2023

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

July 17, 2025

Results First Posted

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations