Status:
COMPLETED
Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
Lead Sponsor:
American Corneal Consultants
Collaborating Sponsors:
Science in Vision
Alcon Research
Conditions:
Refractive Errors
Eligibility:
All Genders
20+ years
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 i...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 21 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04495829
Start Date
July 24 2020
End Date
April 21 2021
Last Update
July 20 2023
Active Locations (5)
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1
Woolfson Eye Institute
Atlanta, Georgia, United States, 30328
2
North Suburban Eye Specialists
Coon Rapids, Minnesota, United States, 55433
3
TLC Laser Eye Center
Chesterfield, Missouri, United States, 63017
4
Laser Defined Vision
Greensboro, North Carolina, United States, 27401