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

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Phorcides	Phorcides Analytical Engine	Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software.

Primary Outcome Measures

Name	Time	Method
Residual Refractive Cylinder	3 months postop	Residual refractive cylinder in diopters

Secondary Outcome Measures

Name	Time	Method
Uncorrected Distance Visual Acuity	3 months postop	Uncorrected visual acuity at distance (4-6m)
Residual Refractive Sphere	3 months postop	Residual refractive spherical equivalent in diopters
Satisfaction and Vision	3 months postop	A questionnaire related to visual quality and satisfaction after surgery

Locations (5): 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