NCT05888337

Brief Summary

The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

May 25, 2023

Last Update Submit

December 7, 2023

Conditions

MyopiaAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group

    3 months postoperatively

Secondary Outcomes (1)

  • Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group

    3 months postoperatively

Other Outcomes (6)

  • Percentage of eyes with monocular UDVA of logMAR 0.00 (20/20) in each group

    3 months postoperatively

  • Mean/SD of residual refractive error and centroid of manifest refraction (dioptric magnitude of residual astigmatism and residual SE)

    3 months postoperatively

  • Percentage of eyes with postoperative UDVA equal to or better than their preoperative CDVA

    3 months postoperatively

  • +3 more other outcomes

Study Arms (2)

Contoura LASIK with Phorcides planning strategy

Device: Contoura LASIK with Phorcides planning strategy

Contoura LASIK with manifest refraction planning strategy

Device: Contoura LASIK with manifest refraction planning strategy

Interventions

Contoura LASIK with Phorcides planning strategyDEVICE

Bilateral treatment with topography guided LASIK

Contoura LASIK with Phorcides planning strategy
Contoura LASIK with manifest refraction planning strategyDEVICE

Bilateral treatment with topography guided LASIK

Contoura LASIK with manifest refraction planning strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.

You may qualify if:

  • years old and above
  • Preoperative total corneal Pachymetry 490um or above
  • BCVA 20/20 or better
  • Stable refractive error \<0.50D MRSE change in preceding year
  • Good general and ocular health
  • Preoperative exam completed within three months of surgery
  • Soft contact lens wear discontinued 3 days prior to preoperative exam and the procedure
  • Residual stromal bed greater than 270um
  • Candidates who qualify for Contoura treatment OU (≤ -8.0 D SPH and ≤ -3.0 D CYL)
  • Candidates who elect to target both eyes targeted for emmetropia
  • ≤ -3.0 D Oblique astigmatism as defined as an axis between 30-60 degrees or between 120-150 degrees

You may not qualify if:

  • Subjects with usual relative and absolute contraindications for LASIK surgery (subjects with severe dry eye, subjects with recurrent corneal erosion, subjects with uncontrolled Glaucoma, subjects with collagen vascular disorders, keratoconus or signs of keratoconus, Uncontrolled Diabetes, Herpes, corneal dystrophies or degeneration; any irregular astigmatism)
  • Pachymetry below 490
  • Autoimmune or immunodeficiency diseases, Pregnant or nursing women
  • Subjects with signs of inability to understand consent for study and procedure planned
  • Subjects with history of previous ocular 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)

Bismarck Lasik

Bismarck, North Dakota, 58501, United States

Location

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Stephen A Wexler, MD

    Bismarck Lasik

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

June 20, 2023

Primary Completion

December 5, 2023

Study Completion

December 5, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)