Skip to main content
OpenTrials
Completed

NCT Number: NCT05848817

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mann Eye Institute

Houston, Texas, 76134-2099, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contoura LASIK

Device

Subjects receiving Phorcides Planned Contoura LASIK

Primary outcomes

  1. Subject Satisfaction

    Time frame: 3 Months Postoperative

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

Secondary outcomes

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

    Time frame: 3 Months Postoperative

Other outcomes

  1. PROWL Questionnaire

    Time frame: 3 Months Postoperative

    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).

  2. OSDI Score

    Time frame: 3 Months Postoperative

    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.

Sponsors and collaborators

Lead sponsor

Mann Eye Institute

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2023
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.