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

American Corneal Consultants

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Phorcides Analytical Engine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04495829

ML-2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

Phorcides

Description:

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

Treatment:

Device: Phorcides Analytical Engine