Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Contoura LASIK

Detailed Description

This study is a single site, single-arm, prospective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 week, 1 month, and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and topography, aberrometry, and administration of the OSDI and PROWL questionnaires.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 76134-2099
      • Mann Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Appropriate candidate for uncomplicated bilateral LASIK surgery
• Gender: Males and Females.
• Age: 21 to 39 years of age.
• Refractive error range - SE refractive errors up to 0.00 to -9.00 D with maximum cylinder up to 3.00 D and sphere ≤ -8.00 D.

• If currently wearing contact lenses:

  • Soft CTL wearers discontinue for minimum 3 days
  • RGP CTL wearers discontinue for 1 month per decade of wear
  • Stable refraction (2 consecutive manifest refractions within 0.25 SE)
  • Stable K readings (2 consecutive K readings in 2 consecutive visits)
• Residual bed thickness 250um or greater
• Willing and able to comply with scheduled visits and other study procedures.
• Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Contoura LASIK; Subjects receiving Phorcides Planned Contoura LASIK.	Device: Contoura LASIK; Subjects receiving Phorcides Planned Contoura LASIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D	3 Months Postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI Score	The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.	3 Months Postoperative
PROWL Questionnaire	PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items).	3 Months Postoperative

Collaborators and Investigators

• Sponsor: Mann Eye Institute
• Collaborators: Sengi
• Investigators: Principal Investigator: Phillip Brunson, OD, Mann Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: PB-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