Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism

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.

Study Overview

• Status: Terminated
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Contoura LASIK with Phorcides planning strategy; Device: Contoura LASIK with manifest refraction planning strategy

Detailed Description

This study is a randomized, prospective contralateral eye study of visual outcomes in eyes planned with Phorcides compared to eyes planned using the manifest refraction after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 3 months postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration of a questionnaire.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Bismarck Lasik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Contoura LASIK with Phorcides planning strategy	Device: Contoura LASIK with Phorcides planning strategy; Bilateral treatment with topography guided LASIK
Contoura LASIK with manifest refraction planning strategy	Device: Contoura LASIK with manifest refraction planning strategy; Bilateral treatment with topography guided LASIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group	3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of eyes that gained 1 or more lines postoperative CDVA and preoperative CDVA		3 months postoperatively
Percentage of subjects that report overall visual preference of the Phorcides planned eye vs manifest refraction planned eye		3 months postoperatively
Quantitative rating of overall satisfaction of vision in each eye	Satisfaction will be measured using a questionnaire. Subjects will rate satisfaction with vision in each eye using the scale: Completely Dissatisfied; Very Dissatisfied; Somewhat Dissatisfied; Somewhat Satisfied; Very Satisfied; Completely Satisfied	3 months postoperatively

Collaborators and Investigators

• Sponsor: Bismarck Lasik
• Collaborators: Sengi
• Investigators: Principal Investigator: Stephen A Wexler, MD, Bismarck Lasik

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: SW-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes