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

Completed

Conditions studied: Refractive Errors

In brief

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.

Key facts

Study ID

NCT04495829

Run by

American Corneal Consultants

People needed

70

Starts

2020-07-24

Expected to finish

2021-04-21

Last updated by the study team

2023-07-20

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Woolfson Eye Institute — Atlanta, Georgia, United States
• North Suburban Eye Specialists — Coon Rapids, Minnesota, United States
• TLC Laser Eye Center — Chesterfield, Missouri, United States
• Laser Defined Vision — Greensboro, North Carolina, United States
• Mann Eye Institute and Laser Centers — Houston, Texas, United States

Full record on ClinicalTrials.gov

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