N/A
N=70
Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
Refractive Errors
Bottom Line
View on ClinicalTrials.gov: NCT04495829 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Residual Refractive Cylinder — 0.04 diopters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Phorcides Analytical Engine (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- American Corneal Consultants
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Refractive Cylinder |
0.04 | — |
| SECONDARY Uncorrected Distance Visual Acuity |
-.11 | — |
| SECONDARY Residual Refractive Sphere |
0.08 | — |
| SECONDARY Satisfaction and Vision |
65; 0; 65; 0; 65; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04495829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.