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Completed

NCT Number: NCT04495829

Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software

The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Woolfson Eye Institute, Atlanta, Georgia, United States

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About this study

The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms.

The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Candidate for Contoura excimer laser vision correction
  • Gender: males and females.
  • Age: 20 or older
  • Willing and able to provide written informed consent for participation in the study.
  • Willing and able to comply with scheduled visits and other study procedures.
  • Good ocular health, with no pathology that compromises visual acuity (other than refractive error)
  • Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye being treated
  • Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up to -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D
  • Desire good vision at distance in both eyes

Exclusion criteria

  • Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, Fuchs' dystrophy, etc.)
  • Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or corneal transplant, DSAEK, DMEK, lamellar keratoplasty)
  • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
  • Desire for good uncorrected near vision in one or both eyes
  • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial
  • Unsuitability for the trial, in the opinion of the investigator, for any reason
  • Pregnancy or desire to become pregnant during the trial
  • Intraoperative complications.

Treatment and study plan

Phorcides Analytical Engine

Device

Surgery planning using the Phorcides analytical engine.

Other names: Phorcides

Primary outcomes

  1. Residual Refractive Cylinder

    Time frame: 3 months postop

    Residual refractive cylinder in diopters

Secondary outcomes

  1. Uncorrected Distance Visual Acuity

    Time frame: 3 months postop

    Uncorrected visual acuity at distance (4-6m)

  2. Residual Refractive Sphere

    Time frame: 3 months postop

    Residual refractive spherical equivalent in diopters

  3. Satisfaction and Vision

    Time frame: 3 months postop

    A questionnaire related to visual quality and satisfaction after surgery

Sponsors and collaborators

Lead sponsor

American Corneal Consultants

Other

Collaborators

  • Alcon Research
  • Science in Vision

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Jul 20, 2023

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.

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